GE Healthcare; LLC          Dec-13-2013       Multi Absorber Original; Disposable – Multi Absorber Original; DisposableM1173310 Multi Absorber Original; Disposable; package of 6 pcs;GE Healthcare Finland OyMade in USRx OnlyThe GE Healthcare Multi Absorber Original; Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS); the GE Healthcare EZchange manifold; the GE Healthcare Compact Block; and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air; oxygen; nitrous oxide; halothane; enflurane; isoflurane; desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.         GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber.

Nephros Inc       Dec-17-2013       Nephros SafeSpout – Nephros SafeSpoutManufacturer: Nephros Inc. 41 Grand Avenue; River Edge; NJ 07661Assembled at : MEDICA 41036 Medolla; ItalyFilters are packaged in a Tyvek pouch and then placed inside a cardboard box.15 filters per boxThe Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose        Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.

Nephros Inc       Dec-17-2013       Nephros SafeShower – 1) Nephros SafeShower FH – 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237Manufactured by : Nephros; Inc. 41 Grand Ave; River Edge; NJ 07661Assembled at MEDICA 41036 Medolla; Italy The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose       Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.

Abbott Diabetes Care; Inc.           Dec-17-2013       FreeStyle Blood Glucose Test Strips – FreeStyle Blood Glucose Test Strips;For in vitro diagnostic testing.50 countUPC 6 99073 12050 2;Freestyle Blood Glucose Test Strips; for Institutional Use only50 count:UPC  6 99073 70792 5Manufactured by Abbott Diabetes Care Inc. Alameda; CA.The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger; upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus; and it is not intended for use on neonates or arterial blood.      Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood  Glucose Meters; FreeStyle Flash Blood Glucose Meters and the FreeStyle blood  glucose meter built into the OmniPod system. Erroneously low results that are not recognized may pose significant risks to your health.

Abbott Diabetes Care; Inc.           Dec-17-2013       FreeStyle Lite Blood Glucose Test Strips – FreeStyle Lite Blood Glucose Test Strips;For in vitro diagnostic testing.50 count; 100 count Product  of Ireland;UPC 6 99073 70819 9; – 50 countUPC 6 99073 70822 9 – 50 countUPC 6 99073 71026 0 – 50 countUPC  6 99073 70827 4 – 100 countManufactured by Abbott Diabetes Care Inc. Alameda; CA.The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger; upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus; and it is not intended for use on neonates or arterial blood.                Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood  Glucose Meters; FreeStyle Flash Blood Glucose Meters and the FreeStyle blood  glucose meter built into the OmniPod system. Erroneously low results that are not recognized may pose significant risks to your health.

Nephros Inc       Dec-17-2013       Nephros Dual Stage Ultra Filter – Nephros Dual Stage Ultra Filter (DSU) BrochureDocument 60-3003Revisions: 0; 1; 2Product Usage:  A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.                Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.



C.L.R. Medicals International; Inc.             Dec-20-2013       Viscocel and Viscocel Plus – Viscocel and Viscocel Plus.These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery; such as to maintain anterior chamber depth; preserve tissue integrity; protect tissue from surgical trauma; or function as a tamponade during retinal reattachment.             CLR Medicals International Inc.; initiated a nationwide recall of Viscocel and Viscocel Plus; in response to FDA inspection findings of deficiencies in the Quality System Regulations for Medical Device Manufacturers; 21 Code of Federal Regulation (CFR) Part 820 and lack of Premarket Approval (PMA) for devices sold or distributed in domestic commerce.  The Viscoelastic products; intended for human

CareFusion 303; Inc.        Dec-20-2013       Alaris PC unit model 8000 and 8015 – Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600.Product Usage:  The Alaris PC unit is the central programming; monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under the Alaris System. The Auto ID is a barcode scanner.               CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because  the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.

Philips Medical Systems; Inc.      Dec-02-2013       Easy Diagnost Eleva – Easy Diagnost ElevaUniversal Fluoroscopic applications                The delivered application software was an outdated version to the model of equipment.

Siemens Healthcare Diagnostics; Inc.      Dec-02-2013       Dimension Vista(R) Intelligent Lab Systems; Dimension Vista(R) 500 and Dimension Vista(R) 1500 – Rel – Dimension Vista(R) 500 and Dimension Vista(R) 1500 – Reloaded Vista Vials – limited to systems using software versions 3.4 and 3.5.1.Diagnostic device intended to determine a variety of analytes in human body fluids.    There is the potential for the vial volume of "in use" Vista calibrators; controls; or sample diluent to incorrectly revert to full volume when removed and reloaded.  Dimension Vista(R) 500 and Dimension Vista(R) 1500 – Reloaded Vista Vials – limited to systems using software versions 3.4 and 3.5.1

Siemens Healthcare Diagnostics; Inc.      Dec-03-2013       Siemens syngo(R) Lab Data Manager – Version VA11B and VA12A – syngo(R) Lab Data Manager – Version VA11B and VA12A SystemsSecurely consolidates data from multiple lab instruments; the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification; integrated QC capabilities; browser-based connectivity supporting up to 25 concurrent users; remote services to help keep systems running optimally and also has audit trail capabilities.            Under certain conditions the system may not perform as intended; causing the release of results to the Laboratory Information System that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.

CareFusion 303; Inc.        Dec-03-2013       VersaSafe Extension Set – VersaSafe Extension Set; Model No. 21000M-007                CareFusion is recalling the VersaSafe Extension IntravascularAdministration Set because it may have excessive adhesivewhich will prevent the male spin collar to operate as intended.

Intuitive Surgical; Inc.     Dec-03-2013       Patient Side Manipulator – Assembly; Patient Side Manipulator on da Vinci Surgical Systems:da Vinci S Surgical System;da Vinci SI Surgical Systemda Vinci Si-e Surgical System;Manufactured by Intuitive SurgicalSunnyvale; CA 94086.The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS2000/3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes; blunt and sharp endoscopic dissectors; scissors; scalpels; ultrasonic shears; forceps/pick-ups; needle holders; endoscopic retractors; stabilizers; electro cautery and accessories for endoscopic manipulation of tissue; including grasping; cutting; blunt and sharp dissection; approximation; ligation; electro cautery; suturing; and delivery and placement of microwave and cryogenic ablation probes and accessories; during urologic surgical procedures; general laparoscopic surgical procedures; gynecologic laparoscopic surgical procedures; general cardiovascular and non-cardiovascular thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system is indicated for adult and pediatric use       Reports of friction within certain instrument arms can interrupt smooth instrument motion. This can be felt by the surgeon as resistance in the movement of the master.In this situation; the instrument can stall momentarily and then suddenly catch-up to the master position if the surgeon pushes through the resistance.

Siemens Medical Solutions USA;  Inc       Dec-03-2013       ARTISTE Linear Accelerator – SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG; MEDICAL SOLUTIONS; Roentgenstrasse 19-21; Kemnath; GERMANY 95478 and distributed SIEMENS Healthcare IM CR RO; CR Radiation Oncology; Martinez; CA      SIEMENS became aware of two (2) customer complaints concerning a safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattening filter free) beams. In case there are many long periods of field shape changes in a treatment plan; the dose due to dark current radiat

Siemens Medical Solutions USA;  Inc       Dec-03-2013       ONCOR series Linear Accelerator – SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG; MEDICAL SOLUTIONS; Roentgenstrasse 19-21; Kemnath; GERMANY 95478 and distributed SIEMENS Healthcare IM CR RO; CR Radiation Oncology; Martinez; CA.               SIEMENS became aware of two (2) customer complaints concerning a safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattening filter free) beams. In case there are many long periods of field shape changes in a treatment plan; the dose due to dark current radiat

Varian Medical Systems; Inc.      Dec-03-2013       C-Series: Clinac; Trilogy; Trilogy Tx. ; Novalis high energy linear accelerators – C-Series:  Clinac; Trilogy; Trilogy Tx. ; Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7; 8 and 9. The UNIQUE is not sold in the US.Product Usage:  The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions; tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions; tumors and conditions anywhere in the body where radiation treatment is indicated.  This correction is to notify users that that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation.

Smith & Nephew Inc      Dec-04-2013       GENESIS(R) II; POSTERIOR STABILIZED ARTICULAR INSERT – GENESIS(R) II; POSTERIOR STABILIZED ARTICULAR INSERT; SIZE 1-2; 13 MM QTY: (1); REF 71420806; STERILE EO; Smith & Nephew; Inc. Memphis; TN 38116 USAOrthopedic       The Tyvek(TM) lid on one; or both; of the two trays that form adouble barrier around the insert may not have been adequately sealed.

Abbott Point Of Care Inc.             Dec-04-2013       Abbott i-STAT PT/INR cartridges – Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc.; Princeton; NJ 08540The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System; the PT/INR test is to be used by trained health care professionals in accordance with a facility’s policies and procedures.               Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR.

Smith & Nephew Inc      Dec-04-2013       GENESIS(R) II; MOBILE BEARING ARTICULAR INSERT RIGHT – GENESIS(R) II; MOBILE BEARING ARTICULAR INSERT RIGHT; SIZE 5; 9 MM QTY: (1); REF 71621509; STERILE EO; Smith & Nephew; Inc. Memphis; TN 38116 USAOrthopedic    The Tyvek(TM) lid on one; or both; of the two trays that form adouble barrier around the insert may not have been adequately sealed.

Smith & Nephew Inc      Dec-04-2013       GENESIS(R) II; PS HIGH FLEXION ARTICULAR INSERT – GENESIS(R) II; PS HIGH FLEXION ARTICULAR INSERT; SIZE 3-4; 13 MM  QTY: (1); REF 71420820; STERILE EO; Smith & Nephew; Inc. Memphis; TN 38116 USAOrthopedic    The Tyvek(TM) lid on one; or both; of the two trays that form adouble barrier around the insert may not have been adequately sealed.

Smith & Nephew Inc      Dec-04-2013       GENESIS(R) II; PS HIGH FLEXION ARTICULAR INSERT – GENESIS(R) II; PS HIGH FLEXION ARTICULAR INSERT; SIZE 5-6; 11 MM QTY: (1); REF 71421516; STERILE EO; Smith & Nephew; Inc. Memphis; TN 38116 USAOrthopedic    The Tyvek(TM) lid on one; or both; of the two trays that form adouble barrier around the insert may not have been adequately sealed.

Smith & Nephew Inc      Dec-04-2013       GENESIS(R) II; PS HIGH FLEXION ARTICULAR INSERT – GENESIS(R) II; PS HIGH FLEXION ARTICULAR INSERT; SIZE 5-6; 9 MM   QTY: (1); REF 71421515; STERILE EO; Smith & Nephew; Inc. Memphis; TN 38116 USAOrthopedic                The Tyvek(TM) lid on one; or both; of the two trays that form adouble barrier around the insert may not have been adequately sealed.

Smith & Nephew Inc      Dec-04-2013       GENESIS(R) II; PS HIGH FLEXION ARTICULAR INSERT – GENESIS(R) II; PS HIGH FLEXION ARTICULAR INSERT; SIZE 3-4; 9 MM   QTY: (1); REF 71421508; STERILE EO; Smith & Nephew; Inc. Memphis; TN 38116 USAOrthopedic                The Tyvek(TM) lid on one; or both; of the two trays that form adouble barrier around the insert may not have been adequately sealed.

Boston Scientific Corporation     Dec-04-2013       Navigator HD – Navigator HD  l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280; RDF Catalog M0062502290; Sterile.Indicated for use in endoscopic procedures to facilitate the passage of endoscopes; urological instruments and for the injection of fluids into the urinary tract.          The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.

Boston Scientific Corporation     Dec-04-2013       Navigator HD – Navigator HD  l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270; RDF Catalog No 250-227; Sterile.Indicated for use in endoscopic procedures to facilitate the passage of endoscopes; urological instruments and for the injection of fluids into the urinary tract.          The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.

Boston Scientific Corporation     Dec-04-2013       Navigator HD – Navigator HD  l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280; RDF Catalog No 250-228; Sterile.Indicated for use in endoscopic procedures to facilitate the passage of endoscopes; urological instruments and for the injection of fluids into the urinary tract.          The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.

Cincinnati Sub-Zero Products Inc               Dec-04-2013       Blanketrol III Data Export Software – Blanketrol III Data Export Software Version 1.10The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer; without controlling or altering the function or parameters of the Blanketrol III.     During a customer inquiry regarding a beta version of  the Bill Data Export Software; Model USB-127; it was discovered that the wrong software version was released to a customer.

CareFusion 303; Inc.        Dec-04-2013       SmartSite Low Sorbing Infusion Sets – SmartSite Low Sorbing Infusion Set with Texium Close Male Luer; Model No. 24301-0007TThe SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient’s artery or vein.          CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing.

Sunrise Medical (US) LLC              Dec-05-2013       Sunrise Brand Zippie  Voyage – Sunrise Brand Zippie  Voyage; Chair with Casters; Early Intervention Device (Stroller);  Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC.; Fresno; CA.Used by a person to move from one place to another while sitting.              There is a remote possibility for the plastic latch to deform over the lifetime of use.  When this happens there is the possibility for the seat to become dislodged from the base. And when not using the positioning strap; there is a risk that the occupant could slide out of the seat and sustain injury.

Olympus America Inc.    Dec-05-2013       THUNDERBEAT – TB-0545PC: THUNDERBEAT 5 mm ; 45 em; Pistol Grip TB-0535PC: THUNDERBEAT 5 mm; 35 em; Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm; 45 em; In line Grip TB-0535IC: THUNDERBEAT 5 mm; 35 em; Inline Grip TB-0520IC: THUNDERBEAT 5 mm; 20 em; In line Grip TB-051 OIC: THUNDERBEAT 5 mm; I 0 em; In line GripTB-545FC: THUNDERBEAT 5 mm; 45 em; Front Actuated GripTB-0535FC: THUNDERBEAT 5 mm; 35 em; Front Actuated GripThe Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open; laparoscopic (including single-site surgery); and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.              Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures; including cracking; breaking; or deformation of the components of the probe tip or jaw.

Synthes USA HQ; Inc.     Dec-05-2013       Synthes Titanium Trochanteric Fixation Nail (TFN)System – Titanium Trochanteric Fixation Nail (TFN)SystemIntended to treat stable and unstable fractures of the proximal femur.              Three lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.

Synthes USA HQ; Inc.     Dec-05-2013       Synthes Zero-P VA Implant 7 MM Height Parallel Sterile – Synthes Zero-P VA Implant 7 MM Height Parallel SterileThe Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1.         A potential non conformance was identified with the Zero-P VA plate where the screw could back out if the blocking mechanism is not visually confirmed to properly cover the head of the screw.

Ge Healthcare It               Dec-05-2013       GE Centricity Web – The GE Centricity Web; Software Version 3.0x; is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise Web is not intended for primary diagnosis. The Centricity Enterprise Web is available as a supplemental sub-system to Centricity PACS or as a stand alone Web-based image and information distribution system. The Centricity Enterprise Web provides both the server software and a client application; which utilizes off the shelf browser technology. Centricity Enterprise Web supports several interface protocols which allows the system to be integrated with any image or information systems such as a hospital information system (HIS); radiology information system (RIS); or electronic medical record (EMR); which supports one of the supported integration protocols.     GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient safety. The WADO (Web Access to DICOM Objects) interface allows for embedding DICOM images as JPEGs on a web page and is available as a licensed operation on Centricity Web. When rejected images are archived by Centricity PACS to Enterprise Archive; an

Centurion Medical Products Corporation              Dec-06-2013       Centurion Sterile # 84 Rubber Bands – Centurion Sterile # 84 Rubber Bands Reorder EB84;  Caution: This product contains natural rubber latex  which may cause allergic reactions. LATEX FREE ;   CAUTION: FEDERAL lAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIANSingle Use Onlybands items together and podiatry office uses bands as tourniquet on toe during in grown toenail procedure                Package labeling indicates both "latex free"  and "contains natural rubber latex" . The rubber bands do contain natural rubber latex.   This could cause a significant risk to users with latex allergies.

Karl Storz Endoscopy America Inc             Dec-06-2013       Axillent Debakey Grasping Forceps – Axillent Debakey Grasping Forceps; Part No. 33821DYDIn general the surgeons use 33821DYD Debakey forceps to grasp tissue.        KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps.

Iba Dosimetry Gmbh      Dec-06-2013       iba COMPASS SW Version 3.0 – iba COMPASS SW Version 3.0; Catalog Number CS10-100 (medical linear accelerator)radiological          The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation. Under certain conditions this problem generates too large ROI voxel volumes causing erroneous dose statistics and DVHs.

Maquet Cardiovascular; LLC        Dec-06-2013       Vasoview Hemopro Endoscopic Vessel Harvesting System – Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne; NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation; and for patients requiring blunt dissection of tissue including dissection of blood vessels; dissection of blood vessels oft he extremities; dissection of ducts and other structures int he extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura including nerves blood vessels and other tissues of the chest wall.             Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" for the Hemopro VH-30000; "Hemopro 1"

Zimmer; Inc.       Dec-06-2013       NexGen Complete Knee Solution – NexGen Complete Knee SolutionCR Articular Surface Provisional-Purple 9mm HeightNonsterileDevices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis; collagen disorders; post-traumatic loss of joint configuration; flexion deformities; and in revision of previous surgical attempts.            This is an expansion of the June 2013 recall related to NexGen Micro components due to a component compatibility issue.  Since the initiation of this recall; five (5) additional instruments have been identified that are associated only with the NexGen Micro components.  Given this; all lots of these additional instruments are now being recalled as well.  There is the potential for these devices

Zimmer; Inc.       Dec-06-2013       NexGen Complete Knee Solution – NexGen Complete Knee SolutionPorous Patella Drill Guide-29mm dia./10mm thicknessNon sterile; Rx OnlyDevices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis; collagen disorders; post-traumatic loss of joint configuration; flexion deformities; and in revision of previous surgical attempts.               This is an expansion of the June 2013 recall related to NexGen Micro components due to a component compatibility issue.  Since the initiation of this recall; five (5) additional instruments have been identified that are associated only with the NexGen Micro components.  Given this; all lots of these additional instruments are now being recalled as well.  There is the potential for these devices

Zimmer; Inc.       Dec-06-2013       NexGen Complete Knee Solution – NexGen Complete Knee SolutionCR Articular Surface Provisional-Striped Green 9mm Height NonsterileDevices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis; collagen disorders; post-traumatic loss of joint configuration; flexion deformities; and in revision of previous surgical attempts.               This is an expansion of the June 2013 recall related to NexGen Micro components due to a component compatibility issue.  Since the initiation of this recall; five (5) additional instruments have been identified that are associated only with the NexGen Micro components.  Given this; all lots of these additional instruments are now being recalled as well.  There is the potential for these devices

Ethicon; Inc.       Dec-06-2013       Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device – Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo; Puerto Rico 00969.Intended for general soft tissue approximation where use of an absorbable suture is appropriate.               Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.

Zimmer; Inc.       Dec-06-2013       NexGen Complete Knee Solution – NexGen Complete Knee SolutionPorous Patella Drill Guide-26mm dia./10mm thicknessNon sterile; Rx OnlyDevices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis; collagen disorders; post-traumatic loss of joint configuration; flexion deformities; and in revision of previous surgical attempts.               This is an expansion of the June 2013 recall related to NexGen Micro components due to a component compatibility issue.  Since the initiation of this recall; five (5) additional instruments have been identified that are associated only with the NexGen Micro components.  Given this; all lots of these additional instruments are now being recalled as well.  There is the potential for these devices

Zimmer; Inc.       Dec-06-2013       NexGen Complete Knee Solution – NexGen Complete Knee SolutionCR Articular Surface Provisional-Yellow 9mm Height NonsterileDevices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis; collagen disorders; post-traumatic loss of joint configuration; flexion deformities; and in revision of previous surgical attempts.            This is an expansion of the June 2013 recall related to NexGen Micro components due to a component compatibility issue.  Since the initiation of this recall; five (5) additional instruments have been identified that are associated only with the NexGen Micro components.  Given this; all lots of these additional instruments are now being recalled as well.  There is the potential for these devices

Hospira Inc.        Dec-06-2013       RECEPTAL CANISTER – Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira; Inc.;; Lake Forest; IL 60045 USA.Used to isolate suction waste during surgeries; or to clear patient airways; throat or wounds to allow treatment.           Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be achieved due to the canister and liner not properly seating.

Stryker Howmedica Osteonics Corp.       Dec-07-2013       Accolade II 127 Neck Angle Hip Stem – 1) Accolade II 127 Neck Angle Hip Stem; Size # 32) Accolade II 127 Neck Angle Hip Stem; Size #5Howmedica Osteonics Corp.325 Corporate DriveMahwah; NJ 07430 USATelephone # +1 201-831-5000Stryker FranceZAC Satolas Green PusignanAv de Satolas Green69881 MEYZIEU Cedex FranceIntended for cementless application in total or hemiarthroplasty procedures.         Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5.

Cutera; Inc.         Dec-09-2013       truSculpt – Cutera brand truSculpt infrared System (optional); Massager; Vacuum; radio frequency induced heat; Product is manufactured and distributed by Cutera; Inc.; Brisbane; CAThe truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. The truSculpt infrared (optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain; muscle spasms; and increase in local circulation.           Cutera received two adverse events associated with the edge of the electrode; when it was pressed against neck skin over the thyroid cartilage and due to the absence of adequate underlying conductive tissue; increased skin heating occurred. Both patients developed linear welts and blisters consistent with partial thickness thermal burns to the skin.

Arrow International Inc Dec-09-2013       Arrow Transradial Artery Access products – Arrow Transradial Artery Access productsArrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.              There is a risk that the introducer needles packaged within the kits can be partially or fully occluded; which can cause delayed treatment or an adverse event when used on a patient.

Omnyx Llc           Dec-09-2013       Digital Pathology System (DPS) Software; version 1.1 – Digital Pathology System (DPS) Software version 1.1The Omnyx" Integrated Digital Pathology system; which consists of a whole slide scanner and associated software applications; is a scanning; receiving; storing; managing; annotating and computer monitor viewing system for digital whole slide images. Omnyx" products are for in vitro diagnostic use for specific clinical applications; and are intended for research use only on other applications. Specific clinical use applications are indicated in separate clinical specific user guides supplied by Omnyx.               There is an issue associated with Digital Pathology System (DPS) Software; in which the annotation tools within the DPS version 1.1 Image Viewer will display incorrect measurements and area calculations for a region of interest on a scanned slide; under certain conditions.

Zimmer; Inc.       Dec-10-2013       Zimmer Trabecular Metal" Total Ankle Tibial Base and Talar Components – Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment; reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: " Rheumatoid arthritis. " Post-traumatic arthritis. " Degenerative arthritis. This device is intended for cemented use only.        As part of routine manufacturing process monitoring by Zimmer; it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants.  The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish.  This mass media

Zimmer; Inc.       Dec-10-2013       Zimmer Trabecular Metal" Total Ankle Tibial Base and Talar Components – Zimmer Trabecular Metal Total Ankle Tibial Base Component  Sizes 1-6Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment; reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: " Rheumatoid arthritis. " Post-traumatic arthritis. " Degenerative arthritis. This device is intended for cemented use only.        As part of routine manufacturing process monitoring by Zimmer; it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants.  The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish.  This mass media

Zimmer; Inc.       Dec-10-2013       Zimmer Trabecular Metal" Total Ankle Tibial Base and Talar Components – Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment; reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: " Rheumatoid arthritis. " Post-traumatic arthritis. " Degenerative arthritis. This device is intended for cemented use only.        As part of routine manufacturing process monitoring by Zimmer; it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants.  The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish.  This mass media

Synthes USA HQ; Inc.     Dec-10-2013       Synthes Trochanteric Fixation Nail – Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System; the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.               Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.

Beckman Coulter Inc.     Dec-10-2013       Coulter LH 780 Hematology Analyzer – Coulter LH 780 Hematology Analyzer; Part No. 723585;A90728Product Usage:Coulter LH 780 Hematology Analyzer is a is a quantitative; automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.  Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC); white blood cell differential and/or reticulocytes.

Beckman Coulter Inc.     Dec-10-2013       Coulter LH 750 Hematology Analyzer – Coulter LH 750 Hematology Analyzer; Part No. 6605632;A85570Product Usage:The Coulter LH 750 Hematology Analyzer is a quantitative; automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids    Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC); white blood cell differential and/or reticulocytes.

Synthes USA HQ; Inc.     Dec-10-2013       Synthes TomoFix Plates – Synthes TomoFix PlatesThe Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia; lateral proximal tibia; medial and lateral distal femur; treatment of bone and joint deformities; fractures; and malalignment caused by injury or disease such as osteoarthritis.   A labeling correction was initiated related to the Surgical Technique Guide J5606-C "TomoFix Osteotomy System" due to the potential for a surgical delay if the surgeon inserts the superior screws at a lesser angle (4 or 6 degrees) and is not aware that those angles are not present.

Aesculap; Inc.    Dec-11-2013       Aesculap GNI161 Bipolar Foot Control – Aesculap GNI161 Bipolar Foot ControlProduct Usage:The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery; ENT surgery; urology; laparoscopy; and plastic surgery.     Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.

Zimmer; Inc.       Dec-11-2013       NexGen Complete Knee Solutions Stemmed Tibial Component Precoat – NexGen Complete Knee Solutions Stemmed Tibial Component PrecoatNexGen Tibial Baseplates are part of the NexGen systems of semi-constrained; non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; Collagen disorders; and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy; Moderate valgus; varus; or flexion deformities.           Two complaints were received in which it was reported that the stem would not lock into the tibia.  Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold the stem as the connection was too loose. The taper diameter was found to be oversized by .010.

Accumetrics Inc                Dec-11-2013       VerifyNow IIb/IIIa Test; 10-Test Kit – VerifyNow IIb/IIIa Test; 10-Test Kit; Catalog No. 85310;10 tests/box; 690 total tests.The VerifyNow IIb/IlIa Test is a semi-quantitative; whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow lIb/IlIa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician. The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument; a disposable test device and quality control materials. The VerifyNow lIb/IlIa Test is a semi-quantitative; whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide.                Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample.  The correct instruction is to perform the test within 15 minutes of collecting the patient sample.

Steris Corporation           Dec-11-2013       AMSCO Evolution steam sterilizer Transfer Carriage – AMSCO Evolution steam sterilizer Transfer Carriage. Product Usage:Mobile; wheeled transportation unit utilized to carry; load; & unload the Loading Car into and out of steam sterilizer units.             The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force.

Stryker Howmedica Osteonics Corp.       Dec-11-2013       Stryker Orthopaedics – Stryker Orthopaedics Cancellous Bone ScrewHowmedica Osteonics Corp.325 Corporate DriveMahwah; NJ 07430 USAStryker FranceZAC Satolas Green PusignanAv de Satolas Green 69881 Meyzieu Cedex FranceBoth the 6.4 mm diameter; 25mm length; Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter; 40 mm length Cancellous Bone Screws (Cat no 2029-5540-1) are cleared for use in Total Hip Arthroplasty (THA); when implanting Stryker’s Hemispherical Cluster Hole Acetabular Shell Systems and Total Knee Arthroplasty (TKA) when implanting Stryker’s Series 7000 Standard Tibial Tray systems. The use of bone screws; during both THA and TKA are intended as supplemental fixation.              Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm.

GE Healthcare; LLC          Dec-12-2013       HGE Healthcare Patient Monitor B30; Procare Monitor B20; Procare Monitor B40; and Monitor B40 – HGE Healthcare Patient Monitor B30; Procare Monitor B20; Procare Monitor B40; and Monitor B40K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of; and to generate alarms for; multiple physiological parameters of adult; pediatric; and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor B20 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor B20 is not intended for use during MRI. The PROCARE Monitor B20 monitors and displays oscillometric non-invasive blood pressure (systolic; diastolic and mean arterial pressure); invasive blood pressure; end-tidal carbon dioxide; heart/pulse rate; respiration rate; EGG (including arrhythmia and ST segment analysis); temperature with a reusable or disposable electronic thermometer for continual monitoring. Esosophageal/Nasopharyngeal/Tymnpanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myo cardial/Core/Surface temperature; and functional oxygen saturation (Sp0 2) and pulse rate via continuous monitoring ; including monitoring during conditions of clinical patient motion or low perfusion. K120598 (Procare Monitor B40): The PROCARE Monitor 840 is a portable multiparameter unit to be used for monitoring and recording of; and to generate alarms for; multiple physiological parameters of adult; pediatric; and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor 840 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor 840 is not intended for use during MRI. The PROCARE Monitor B40 monitors and displays oscillometric non-invasive blood pressure (systolic; diastolic and mean arterial pressure); invasive blood pressure; end-tidal carbon dioxide; heart/pulse rate; respiration rate; ECG (including arrhythmia and ST segment analysis); temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympaiic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/ Surface temperature; and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring; including monitoring during conditions of clinical patient motion or low perfusion. K130584 (Monitor B40): The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of; and to generate alarms for; multiple physiological parameters of adult; pediatric; and neonatal patients in a hospital environment and during intra-hospital transport. The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI. The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network. The Monitor B40 monitors and displays: ECG (including ST segment; arrhythmia detection); invasive blood pressure; heart/pulse rate; oscillometric non-invasive blood pressure (systolic; diastolic and mean arterial pressure); functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion); temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/ Surface temperature; impedance respiration; respiration rate; airway gases (CO2; O2; N2O; anesthetic agents; anesthetic agent identification and respiratory rate) and Entropy. Product Quantity Distributed (Int) 16;061 (343 US; 15;718 OUS) GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings associated with the B20/B40 V1; B30 and B40 V2 Patient Monitors.The B20; B30 and B40 Patient Monitors set the ECG filter setting incorrectly if the monitor starts with impedance respiration set in the ON position. Instead of the user selected filter; an additional 0.5 Hz high pass filter is used. The

Trumpf Medical Systems; Inc.    Dec-12-2013       Helion S Exam Light or H300 – Helion S Exam Light or H300The device is intended to locally illuminate an examination area of the patient’s body with high intensity light in a clinic or doctor’s practice.               Possible fatigue failure of the plastic joint may occur after an average use of seven years.

Aesculap; Inc.    Dec-13-2013       Aesculap Columbus Revision CoCr 15mm distal and posterior spacers; sizes F5-F7 – Aesculap Columbus Revision CoCr 15mm distal and posterior spacers; sizes F5-F7 The Columbus Revision CoCr 15 mm distal and posterior implant spacers; sizes F5-F7; were not compatible.

Stryker Neurovascular   Dec-13-2013       SUPER COMPLIANT 4MM X 7MM – Stryker brand SUPER COMPLIANT 4MM X 7MM; Catalog Number: M003SSC04070; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed by Stryker Neurovascular; Fremont; CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Stryker Neurovascular   Dec-13-2013       EXCELSIOR SL-10 PRE-SHAPED J 15OCM – Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM; Catalog Number: M0031441930; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed by Stryker Neurovascular; Fremont; CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.         Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Stryker Neurovascular   Dec-13-2013       EXCELSIOR SL-10 150CM 2 TIP – Stryker brand EXCELSIOR SL-10 150CM 2 TIP; Catalog Number: M0031681890; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed by Stryker Neurovascular; Fremont; CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Stryker Neurovascular   Dec-13-2013       EXCELSIOR SL-10 PRE-SHAPED 45 150CM – Stryker brand EXCELSIOR SL-10 PRE-SHAPED 45 150CM; Catalog Number: M0031681900; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed by Stryker Neurovascular; Fremont; CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.         Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Stryker Neurovascular   Dec-13-2013       GDC-10 ULTRASOFT 2MM X 3CM – Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM; Catalog Number: M0033432030; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed by Stryker Neurovascular; Fremont; CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Stryker Neurovascular   Dec-13-2013       GDC VORTX 2MM X 3MM – Stryker brand GDC VORTX 2MM X 3MM; Catalog Number:M00335302340; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed by Stryker Neurovascular; Fremont; CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Stryker Neurovascular   Dec-13-2013       COMPLIANT 4MM X 15MM – Stryker brand COMPLIANT 4MM X 15MM; Catalog Number:M003SRC04150; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed byExcelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.        Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Stryker Neurovascular   Dec-13-2013       COMPLIANT 4MM X 15MM – Stryker brand COMPLIANT 4MM X 20MM; Catalog Number:M003SRC04200; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed by Stryker Neurovascular; Fremont; CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Stryker Neurovascular   Dec-13-2013       SUPER COMPLIANT 7MM X 15MM – Stryker brand SUPER COMPLIANT 7MM X 15MM; Catalog Number: M003SSC07150; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed by Stryker Neurovascular; Fremont; CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Stryker Neurovascular   Dec-13-2013       EXCELSIOR SL-10 PRE-SHAPED J 15OCM – Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM; Catalog Number: M0031681920; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed by Stryker Neurovascular; Fremont; CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.         Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Stryker Neurovascular   Dec-13-2013       COMPLIANT 4MM X 10MM – Stryker brand COMPLIANT 4MM X 10MM; Catalog Number:M003SRC04100; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed by Stryker Neurovascular; Fremont; CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Stryker Neurovascular   Dec-13-2013       COMPLIANT 5MM X 30MM – Stryker brand COMPLIANT 5MM X 30MM; Catalog Number: M003SRC05300; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed by Stryker Neurovascular; Fremont; CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Stryker Neurovascular   Dec-13-2013       EXCELSIOR SL-10 PRE-SHAPED J 15OCM – Stryker brand EXCELSIOR SL-10 PRE-SHAPED C 15OCM; Catalog Number: M0031441940; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed by Stryker Neurovascular; Fremont; CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.         Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Stryker Neurovascular   Dec-13-2013       EXCELSIOR SL-10 PRE-SHAPED J 15OCM – Stryker brand EXCELSIOR SL-10 PRE-SHAPED S 15OCM; Catalog Number: M0031441920; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed by Stryker Neurovascular; Fremont; CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.         Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Stryker Neurovascular   Dec-13-2013       COMPLIANT 4MM X 30MM – Stryker brand COMPLIANT 4MM X 30MM; Catalog Number:M003SRC04300; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed by Stryker Neurovascular; Fremont; CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Stryker Neurovascular   Dec-13-2013       GDC-18 360 18MM X 30CM – Stryker brand GDC-18 360 18MM X 30CM; Catalog Number: M00334818300; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed by Stryker Neurovascular; Fremont; CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Stryker Neurovascular   Dec-13-2013       EXCELSIOR SL-10 PRE-SHAPED 90 150CM – Stryker brand EXCELSIOR SL-10 PRE-SHAPED 90 150CM; Catalog Number: M0031681910; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed by Stryker Neurovascular; Fremont; CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.         Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Stryker Neurovascular   Dec-13-2013       COMPLIANT 5MM X 15MM – Stryker brand COMPLIANT 5MM X 15MM; Catalog Number: M003SRC05150; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed by Stryker Neurovascular; Fremont; CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Stryker Neurovascular   Dec-13-2013       EXCELSIOR 1018 PRE-SHAPED 45 150CM – Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM; Catalog Number: M0031441900; Product is manufactured by Stryker Neurovascular; Cork; Ireland and distributed by Stryker Neurovascular; Fremont; CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents; such as contrast media; and therapeutic agents; such as occlusion coils; into the peripheral; coronary; and neurovasculature. GDC 10; 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms; (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula; (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.         Products were shipped labeled with "use by" dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.

Siemens Healthcare Diagnostics; Inc.      Dec-16-2013       Dimension(R) TACR Flex(R) reagent cartridge (DF107) – Dimension(R) TACR Flex(R) reagent cartridge (DF107)The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of Tacrolimus therapy in kidney and liver transplant patients  Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.

Beckman Coulter Inc.     Dec-16-2013       Access Immunoassay Systems Reaction Vessels – Access Immunoassay Systems Reaction Vessels.The Access Immunoassay System is an in vitro diagnostic device used for the quantitative; semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.               Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels; including the Acess/Access 2 Immunoassay Systems; SYNCRON LXi 725 Clinical System; and UniCel DxC 600i SYNCHRON Access Clinical System because Beckman Coulter has observed an intermittent increase in Access System"Wash Carousel Motion Errors" with specific lots of Access SystemReaction Vessels (RVs). I

Microgenics Corp             Dec-16-2013       CEDIA Tobramycin II Assay – Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay; Catalog Number 100018; Product is manufactured and distributed by Microgenics Corporation; located at Fremont; CA.; part of Thermo Fisher ScientificThe CEDIA Tobramycin II Assay is an in vitro diagnostic medical device intended for the quantitation of Tobramycin in human serum or plasma.              Microgenics Corp.; part of Thermo Fisher Scientific; is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due to calibration stability problem relating to two complaints received.

Intuitive Surgical; Inc.     Dec-16-2013       Mega Needle Driver; 8MM assembly of the da Vinci S  IS1200 and da Vinci Si;  IS2000 – Mega Needle Driver; 8MM assembly of the da Vinci S  IS1200 and da Vinci Si;  IS2000.Manufactured by Intuitive Surgical; Sunnyvale; CA.EndoWrist Instruments; including scissors; scalpels; forceps; needle drivers and electrocautery are intended for endoscopic manipulation of tissue; including: grasping; cutting; blunt and sharp dissection; approximation; ligation; electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.     Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.

Intuitive Surgical; Inc.     Dec-16-2013       Large Needle Driver; 8MM assembly of the da Vinci S  IS1200 and da Vinci Si;  IS2000 – Large Needle Driver; 8MM assembly of the da Vinci S  IS1200 and da Vinci Si;  IS2000.Manufactured by Intuitive Surgical; Sunnyvale; CA.EndoWrist Instruments; including scissors; scalpels; forceps; needle drivers and electrocautery are intended for endoscopic manipulation of tissue; including: grasping; cutting; blunt and sharp dissection; approximation; ligation; electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.     Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.

Instrumentation Laboratory Co.                Dec-16-2013       HemosIL Normal Control 1 UNASSAYED – HemosIL Normal Control 1 UNASSAYEDPart Number: 0020003120   HemosIL Low; Abnormal; Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

Kimberly-Clark Corporation         Dec-16-2013       Kimberly-Clark Single Shot Epidural Pain Management Trays – Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198)Product Usage:The device is designed to provide regional anesthesia. The device may contain syringes; needles and drugs Kimberly-Clark Single Shot Epidural Pain Management Trays contain the BD 7 mL Epilor plastic Luer-Lok LOR Syringes under recall by Becton Dickinson (BD) because the product may stall or stick when traveling within the barrel of the syringe.

Instrumentation Laboratory Co.                Dec-16-2013       HemosIL High Abnormal Control 3 UNASSAYED – HemosIL High Abnormal Control 3 UNASSAYEDPart Number: 0020003320           HemosIL Low; Abnormal; Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

Instrumentation Laboratory Co.                Dec-16-2013       HemosIL Low Abnormal Control 2 UNASSAYED – HemosIL Low Abnormal Control 2 UNASSAYEDPart Number: 0020003220           HemosIL Low; Abnormal; Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

GE OEC Medical Systems; Inc      Dec-17-2013       InstaTrak 3500 Plus; ENTrakTM Plus; InstaTrak 3500; ENTrakTM – InstaTrak 3500 Plus; ENTrakTM Plus; InstaTrak 3500; ENTrakTM Computer-Assisted Navigation Systems (USA);       GE OEC Medical Systems Inc is recalling InstaTrak 3500 Plus; ENTrakTM Plus; InstaTrak 3500; ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products.

mobility unlimited inc     Dec-17-2013       KayserBetten – KayserBetten model IDA bedsProduct Usage: BED; AC-POWERED ADJUSTABLE HOSPITAL Some joints on the doors of a limited number of IDA beds may loosen or separate over time which can cause the doors to drop outward and cause injury.

Biomet; Inc.        Dec-17-2013       CurvTek Eye Needle – outer box: Ref 906768;  CurvTek Eye Needle 22 MM X-large Stainless Steel; Single Use Gamma Sterilized; Rx inner incorrect label:  CurvTek  7 MM Medium; Single Pack Quantity -3; REF 906760 To pass the CurvTek needle; place the jaws of the instrument utilized to grasp the needle on the sides of the needle and orient and needle parallel to the long axis of the instrument. Position the needle to follow the path of the tunnel created by the cartridges. This aligns the needle with the radius of the transosseous tunnel. Advance the needle while rotating the instrument away from the entry point. Gently feed the needle through the length of the tunnel.             Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly  PN: 906760 7mm Medium.

Integra LifeSciences Corp. d.b.a. Integra Pain Management         Dec-17-2013       Integra Kits for Epidural Anesthesia Administration – Integra Disposable; Convenience Kit  Single Shot Epidural Tray  Reorder Number 340269 Rx OnlyProduct Usage:The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general; local or spinal anesthetics. The BD LOR syringe is intended for use; in conjunction with an epidural needle; to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.          Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may stall or stick when travelling within the syringe.

Remel Inc            Dec-17-2013       remel RapID Yeast Plus System – remel RapID Yeast Plus System; 20 tests; Ref: R8311007; IVD; containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B.  Product Usage:  For the biochemical identification of medically important yeast and yeast-like organisms.              The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.

Ortho-Clinical Diagnostics             Dec-17-2013       VITROS Immunodiagnostic Products CA 125 II Calibrators – VITROS CA 125 II CalibratorsFor use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems; VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 defined antigen in human serum and plasma (EDTA or heparin).   Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products CA 125 II Reagent Pack and Calibrators due to a positive shift in patient results.

Karl Storz Endoscopy America Inc             Dec-17-2013       Broncho Flexible Fiberscope – Broncho Flexible Fiberscope; models: 11001BN1; 11002BD1; 11004BC1; and 11009BC1." Examination and treatment of the tracheobronchial tree Contraindications for Bronchoscopy " Uncontrolled angina; uncontrolled heart failure; or serious uncontrolled ventricular arrhythmias " Uncontrolled hypertension " Bleeding disorder or use of anticoagulants.               KARL STORZ Endoscopy America; Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU); which is not listed in STERRAD systems claims for interior endoscope lumens.

Karl Storz Endoscopy America Inc             Dec-17-2013       Intubation Flexible Fiberscope – Intubation Flexible Fiberscope; Models: 11301AA1; 11301BN1; 11302BD1; 11302BD2; 11304BC1; 11340BC1; 11301BND1; 11302BDD1; and 11302BDD2." Transoral intubation " Transnasal intubation " Evaluation of placement of endotracheal and double lumen endotracheal tubes " Provide visual access to the larynx and tracheobronchial tree.     KARL STORZ Endoscopy America; Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU); which is not listed in STERRAD systems claims for interior endoscope lumens.

Remel Inc            Dec-18-2013       Streptex* kit; Ref R30950501 ZL50; Rapid latex test for Streptococcal grouping – Streptex* kit; Ref R30950501 ZL50; Rapid latex test for Streptococcal grouping; IVD.  The kit contains reagent groups A; B; C; D; F; G; a control; and an extraction enzyme.  The firm name on the label is Remel Europe Ltd.; Dartford; England.Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci. Reagents are provided for groups A; B; C; D; F and G covering the majority of clinical isolates; group E streptococci are rarely isolated.                The product may give weak or false negative test results.

Remel Inc            Dec-18-2013       Streptex* Latex D; Ref R30950901 ZL54 – Streptex* Latex D; Ref R30950901 ZL54; IVD; Latex reagent for streptococcal group D; 50 tests per box.  The firm name on the label is Remel Inc.; Lenexa; KS; Manufactured by Remel Europe Ltd.; Dartford Kent; UK.Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci      The product may give weak or false negative test results.

3M Company – Health Care Business       Dec-18-2013       Imprint II and Paradigm impression material – 3M ESPE Imprint II Regular Body ; Catalog Number 9379; and Paradigm Regular Body VPS; Catalog Number 5315; Impression Material that are intended to reproduce the structure of a patients teeth.Impression Materials are composed of hydrophilic vinyl polysiloxane impression materials; designed for making precise crown and bridge; inlay; onlay; veneer preparations; removable denture and partial denture impressions.      Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the dental impression.

Roche Diagnostics Operations; Inc.          Dec-18-2013       MagNA Pure 96 System – MagNA Pure 96 SystemVersion 1.0Software Version 2.0Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood; serum; blood cells; culture cells; tissue; bacteria; fungi) by the use of the specially designed MagNA Pure reagent kits; automated filling of different kinds of PCR reaction vessels.   This issue is only relevant for customers importing xml files into the MagNA Pure 96 IVD instrument software for sample identification.  There is a potential for sample mismatch when using the MagNA Pure 96 IVD instrument (catalog number 06541089001). Importing an order file in xml format to the MagNA Pure 96 IVD instrument software may result in a wrong sequence of samples in the graphical overvi

Baxter Corporation Englewood  Dec-18-2013       ABACUS TPN Calculation Software; Baxa – ABACUS TPN Calculation Software; Baxa: 8300-0045 ABACUS CE (Calculator Edition); 8300-0046 ABACUS SE (Single-Workstation Edition); 8300-0047 ABACUS ME (Multi-Workstation Edition)ABACUS is a Windows – based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for TPN order calculations. Other uses of Abacus include:  non-TPN volumes administered to patients on TPN therapy in order calculations; CVVH calculations;  Cardioplegia (Buckburg) calculations;  Epidural calculations;  Dilutions from concentrated ingredient;  Combinations of multiple ingredients;  Fractional doses from larger volumes         Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutrition (TPN) Calculation Software versions 2.0 through 3.0 due to the possibility that a patient could receive another patient’s TPN order as a result of data corruption.

Qualigen Inc       Dec-19-2013       FastPack Free T4 Immunoassay – FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for use with the FastPack System.             Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

Qualigen Inc       Dec-19-2013       FastPack Vitamin D Immunoassay – FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin DThe FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer.               Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

CooperVision Inc.            Dec-19-2013       Proclear – ClearSight(TM) Toric 1 day (ocufilcon D); 30 daily disposable contact lenses for astigmatism; STERILE; Rx only — CooperVision Hamble; SO31 4RF; UK – Scottsville; NY 14546 USA – Juana Diaz; PR 00795 USAdaily use disposable contact lenses for astigmatism    Lots were labeled with incorrect expiration dates on secondary package (carton).  The primary package (blister) is marked with the correct expiration date.

Qualigen Inc       Dec-19-2013       FastPack Total PSA Immunoassay – FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA.FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack Total PSA Immunoassay is designed for use with the FastPack System.                Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

Qualigen Inc       Dec-19-2013       FastPack Testosterone Immunoassay – FastPack Testosterone Immunoassay Chemilunescence assay for the determination of TestosteroneThe FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System. Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

CooperVision Inc.            Dec-19-2013       Proclear – Pro clear(R) 1 day Sphere (o mafilcon A); 90 daily disposable contact lenses; STERILE; Rx ONLY — Coopervision Shamble; SO 31 4 RF; UK – Scottsville; NY 14546 USA – Juana Diaz; PR 00795 USAdaily use disposable contact lenses Lots were labeled with incorrect expiration dates on secondary package (carton).  The primary package (blister) is marked with the correct expiration date.

ASI Medical; Inc.               Dec-19-2013       SEAC Advanced Dental System – SEAC Advanced Dental System; Model A591561The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor;vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handpiece connections. The Micadent is used to perform intra oral air abrasion procedures including etching and preparing surfaces for composite restoration. The SEAC Advanced Dental System is substantially similar in design and functions as the SEAC Mobile Dental System manufactured by ASI Medical; Inc. The Micadent is manufactured by Medidents and will be supplied to ASIas a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation. It is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.           ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture.

SpineFrontier; Inc.           Dec-19-2013       PedFuse Reset Screw – PedFuse Reset Screw; Model: 01-80115-55The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic; lumbar; and/or sacral spine.     During routine servicing; it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should haveconsisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.

Smiths Medical ASD; Inc.              Dec-19-2013       Medfusion 4000 Syringe Infusion Pumps – Medfusion 4000 Syringe Infusion PumpsMedfusion 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions; drug solutions; blood or blood products; and enteral feedings in continuous; intermittent; and body weight delivery modes.               Smiths Medical is conducting a recall involving  all Medfusion 4000 Syringe Infusion Pumps.Smiths Medical has identified an issue with electrical shorting at the AC power receptacle. Shorting can occur when saline solution or other conductive fluids (e.g.; potassium chloride) enter the AC power receptacle. When this happens; sparking and/ or flames; accompanied by smoke; may appear at the AC po

Siemens Healthcare Diagnostics; Inc.      Dec-19-2013       Dimension Vista HCYS – Siemens Dimension Vista Homocysteine Flex Reagent CartridgeThe HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum; heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.               Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.

Arrow International Inc Dec-19-2013       Continuous Peropheral Nerve Block Catheter Kit and Set – Continuous Peripheral Nerve Block Catheter Kit and SetContinuous Peripheral Nerve Block Catheter Kit and Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.       A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket; however; the kit contains a stimulator cable with 1.5mm pin.

Integra LifeSciences Corp. d.b.a. Integra Pain Management         Dec-20-2013       Integra Cranial Access Kit – Integra Cranial Access Kit; Model Number HITHSP10; Rx Only.Integra‑ Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP); to monitor CSF; to provide temporary drainage of Cerebrospinal Fluid (CSF); and to monitor ICP. These kits contain all components and accessories required for burr hole access into the cranium.            Integra LifeSciences is voluntarily recalling anyunexpired lots of HITHSP10 Cranial Access Kits due to identified labeling discrepancies.   kit contains DuraPrep and Monocryl sutures whose labeling does not align with the intended use and labeling of the Cranial Access Kit.

Varian Medical Systems; Inc.      Dec-20-2013       Eclipse Treatment Planning System – Plan Parameters workspace withinEclipse Treatment Planning System Version 11 and 13;ARIA Radiation Oncology versions 11 and 13Acuity; versions 11 and 13.Manufactured by Varian Medical SystemsPalo Alto; CA.Used in radiation therapy simulation.       An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected; the Monitor units may change.

Mckesson Information Solutions LLC       Dec-20-2013       McKesson Radiology – McKesson Radiology 12.0; Picture Archiving Communication System (PACSA).             When merging two patient records into one patient record using McKesson Radiology 12.0; the resulting patient record is missing the Contrast Allergy information for the second patient record.

Abbott Vascular; Inc.      Dec-20-2013       HT Connect Peripheral Guide Wire – HT Connect Peripheral Guide WirePart Number   Description1012587          018 HT CONNECT 145 CM1012588          018 HT CONNECT 195 CM1012589          018 HT CONNECT 300 CM1012590          018 HT CONNECT FLEX 145 CM1012591          018 HT CONNECT FLEX 195 CM1012592          018 HT CONNECT FLEX 300 CM1012593          018 HT CONNECT 250T 145 CM1012594          018 HT CONNECT 250T 195 CM1012595          018 HT CONNECT 250T 300 CM  Abbott Vascular has initiated a recall of the HT Connect Peripheral Guide Wires due to a small number of devices exhibiting partial delamination of the PTFE coating.

SpineFrontier; Inc.           Dec-20-2013       PedFuse Reset Screw Inserters – PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111The PedFuse Screw Inserter 05-7 REset; Screw Inserter 05-7 REspond; and Screw Inserter 08-9 REset are used as a screw capture; screw driver; and screw insertion tool in the PedFuse system.  Screw inserters may not mate properly with hex interface of the screws.

SpineFrontier; Inc.           Dec-20-2013       PedFuse Reset Screw Inserters – PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110The PedFuse Screw Inserter 05-7 REset; Screw Inserter 05-7 REspond; and Screw Inserter 08-9 REset are used as a screw capture; screw driver; and screw insertion tool in the PedFuse system.   Screw inserters may not mate properly with hex interface of the screws.

SpineFrontier; Inc.           Dec-20-2013       PedFuse Reset Screw Inserters – PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113The PedFuse Screw Inserter 05-7 REset; Screw Inserter 05-7 REspond; and Screw Inserter 08-9 REset are used as a screw capture; screw driver; and screw insertion tool in the PedFuse system.   Screw inserters may not mate properly with hex interface of the screws.

Ortho-Clinical Diagnostics             Dec-20-2013       VITROS Immunodiagnostic Products Anti-HBs Calibrators & Anti-HBs Reagent Packs – VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results.

B. Braun Medical; Inc.    Dec-21-2013       B. Braun Introcan Safety IV Catheter – B. Braun Introcan Safety IV Catheter PUR 24G; 0.7X19mm-US;  catalog number 4251601-02.  Product Usage:  The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids; drugs; and/or blood components; or to facilitate the placement of vascular access devices such as guidewires; indwelling central venous catheters; peripherally inserted central catheters; and midline catheters into vascular system.  One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.

Ziehm Imaging Inc           Dec-24-2013       Ziehm Imaging GmbH – Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System.Mobile Fluoroscopic Imaging              Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Ziehm Imaging Inc           Dec-24-2013       Ziehm Imaging GmbH – Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System.Mobile Fluoroscopic Imaging      Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Ziehm Imaging Inc           Dec-24-2013       Ziehm Imaging GmbH – Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System.Mobile Fluoroscopic Imaging      Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Ziehm Imaging Inc           Dec-24-2013       Ziehm Imaging GmbH – Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System.Mobile Fluoroscopic Imaging      Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Ziehm Imaging Inc           Dec-24-2013       Ziehm Imaging GmbH – Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System.Mobile Fluoroscopic Imaging      Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Ziehm Imaging Inc           Dec-24-2013       Ziehm Imaging GmbH – Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System.Mobile Fluoroscopic Imaging      Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Ziehm Imaging Inc           Dec-24-2013       Ziehm Imaging GmbH – Ziehm Vision R  C-Arm Interventional Fluoroscopic X-Ray System.Mobile Fluoroscopic Imaging      Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Philips Medical Systems; Inc.      Dec-24-2013       Philips Healthcare – Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support; advanced cardiac support; or defibrillation. It must be used by or on the order of a physician. The HeartStart MRx EtCO2 Option monitors carbon dioxide (CO2) and measures end-tidal carbon dioxide (EtCO2). The option provides an EtCO2 value and a CO2 waveform on the devices display.      MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg

Data Innovations; Inc.    Dec-24-2013       Instrument Manager – Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzerSoftware all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001; v7.00.0002; v7.00.0003; v7.00.0004; v7.00.0005; v8 .00.0001; v8.00.0002; v8.00.0003; and v8 .00.0004          When connected to the Sysmex UF-100; theInstrument Manager driver sysu100i driver software versions 7.00.0001; 7.00.0002; 7.00.0003; 7.00.0004; 7.00.0005; 8.00.0001; 8.00.0002; 8.00.0003;and 8.00.0004; and is configured with option "Strip Zeros from Result" set to "Yes"  may result in  sample error

Siemens Healthcare Diagnostics; Inc.      Dec-24-2013       Siemens Dimension(R) Chemistry Wash (RD701) – Dimension(R) Chemistry Wash (RD701); Siemens Material Number (SMN) 10445052Product Usage:  Used in the Dimension(R) system with the heterogeneous module              Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1; LTN1; FT4; TSH; PBNP and LPBN when using Chemistry Wash lots RD23031; RD23111; RD23241; RD23311; RD23391; and RD23461.  These lots shipped between 12/12/2012 and 3/22/2013.  Internal investigation has confirmed shifts can be encountered in two scenarios:  1 – When an affected l

Siemens Healthcare Diagnostics                Dec-24-2013       IMMULITE /IMMULITE 1000 Folic Acid – IMMULITE/IMMULITE 1000 Systems FOL Folic Acid; REF/Catalog Number LKFO1 (100 tests); Siemens Material Number (SMN) 10380902; IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers — Siemens Healthcare Diagnostics Products Ltd.    An IVD for the quantitative measurement of folic acid in serum; heparinized plasma or ascorbic acid-treated whole blood; as an aid in clinical diagnosis and treatment of anemia.     potential for an accelerated decline in counts per second (CPS) for three  IMMULITE/IMMULITE 1000 Folic Acid kit lots.  This may lead to a failed adjustment before the labeled expiration date is reached.

Smith & Nephew Inc      Dec-26-2013       REFLECTION(R); MICROSTABLE(R); ACETABULAR LINER – REFLECTION(R); MICROSTABLE(R); ACETABULAR LINER; 20o OVERHANG; 28 MM ID; 54-56 OD; QTY: (1); STERILE EO; REF 71742854; Smith & Nephew; Inc. Memphis; TN 38116 USA.Orthopaedic.      One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell.

Clark Laboratories; Inc. (dba;Trinity Biotech USA)              Dec-26-2013       Captia Syphilis IgG – Captia Syphilis-G Test KitProduct Usage:  This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens; to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis). It is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.   Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.

SpineFrontier; Inc.           Dec-26-2013       Invue Screws – Indus Invue Screws: IM71016-XX: 04.5mm; SelfTapping.Used to secure the Invue Anterior Cervical Plate in position.        Mismarked and unmarked screws

SpineFrontier; Inc.           Dec-26-2013       Invue Screws – Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling.Used to secure the Invue Anterior Cervical Plate in position. Mismarked and unmarked screws

SpineFrontier; Inc.           Dec-26-2013       Invue Screws – Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling.Used to secure the Invue Anterior Cervical Plate in position. Mismarked and unmarked screws

SpineFrontier; Inc.           Dec-26-2013       Invue Screws – Indus Invue Screws:  IM71058-XX: 04.2mm; SelfTapping; Tapered.Used to secure the Invue Anterior Cervical Plate in position.     Mismarked and unmarked screws

EOS Imaging       Dec-26-2013       EOS Imaging – steroEOS Workstation with software versions: 1.3; 1.4 and 1.5 used in processing 3D X-ray imagesProduct Usage:  The sterEOS Workstation is a general system for acceptance ; transfer; display and digital processing of two 3D x-ray images.    Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation

Materialise USA LLC        Dec-26-2013       ProPlan CMF – ProPlan CMF  Guide(s) Model(s)REF SD900.008 Description: Single Use Only : Patient-Specific Guide;  Orthognathic; Final  Single  Use Only Rx only.Used as surgical tools to transfer a pre-operative plan to surgery..          Patient Specific Guide contained the incorrect case report.  The case report contains patient specific surgical plan information.

Materialise USA LLC        Dec-26-2013       ProPlan CMF – ProPlan CMF  Guide(s) Model(s)REF SD900.008 Description: Single Use Only : Patient-Specific Guide;  Orthognathic; Intermediate  Single  Use Only Rx only.Used as surgical tools to transfer a pre-operative plan to surgery.   Patient Specific Guide contained the incorrect case report.  The case report contains patient specific surgical plan information.

OrthoPediatrics Corp      Dec-26-2013       ACL Reconstruction System Installation tools – OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set ; Part 01-1008-0040/0047; 6mm; 6.5mm; 7mm; 7.5mm; 8mm; 8.5mm; 9mm; and 10mm.Used with ACL reconstruction system associated surgery.         Part # 01-1008-0040/0047; ACL Sleeve Installation/ Insertion Tool; shipped November 4; 2013 – November 6; 2013  may be etched with the wrong size.

Stryker Howmedica Osteonics Corp.       Dec-27-2013       Stryker Orthopaedics  Rim Impactor Tip – Stryker Orthopaedics  Rim Impactor Tip Product Usage:  Used for MDM surgery.     Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.

Stryker Howmedica Osteonics Corp.       Dec-27-2013       Stryker Orthopaedics  Ball Impactor Tip – Stryker Orthopaedics  Ball Impactor Tip Product Usage:  Used for ADM Surgery.      Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.

Philips Medical Systems; Inc.      Dec-27-2013       Philips Essenta DR – Philips Essenta DR;  a Stationary x-ray system; X-ray systemModel: 712070The Essenta DR is a multifunctional stationary X-ray system; in which the swivel arm rotation; the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent; standing or seated patient and also for lateral exposures. It enables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button; using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command. X-ray system C-arm casting may loosen and fall

Asante Solutions; Inc.    Dec-27-2013       Asante Comfort Infusion Set – Asante Comfort Infusion Set with  110cm tubing & 17mm cannula packaged in 5-packs; singles; or inside a Combination  Kit (FG-5147-4).Manufactured for:Asante SolutionsSunnyvale; CA;Manufactured by:Unomedical;Lejre; Denmark Reports of the infusion tubing disconnecting from the connector; resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.

Asante Solutions; Inc.    Dec-27-2013       Asante Comfort Infusion Set – Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs; singles;or inside a Combination Kit (FG-5127-4).Manufactured for:Asante SolutionsSunnyvale; CA;Manufactured by:UnomedicalLejre; Denmark   Reports of the infusion tubing disconnecting from the connector; resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.

Zimmer; Inc.       Dec-27-2013       Zimmer Periarticular Plating System – FEM COND BUTTRESS PLT; RT.        Based on a review of historic packaging validations; it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity.  This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray; resulted in failure

Asante Solutions; Inc.    Dec-27-2013       Asante Conset Infusion Set – Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs;singles;or inside a Combination Kit (FG-5226-4)Distributed by Asante Solutions;Sunnyvale; CA;Manufactured by Convatec;Lejre; Denmark.                Reports of the infusion tubing disconnecting from the connector; resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.

Zimmer; Inc.       Dec-27-2013       Zimmer Periarticular Plating System – FEM COND BUTTRESS PLT; LT          Based on a review of historic packaging validations; it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity.  This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray; resulted in failure

Zimmer; Inc.       Dec-27-2013       Zimmer Periarticular Locking Plate System – DIST LAT FEM LOCK PLT; RT  Based on a review of historic packaging validations; it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity.  This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray; resulted in failure

Zimmer; Inc.       Dec-27-2013       ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION – ITST THREADED GUIDE PIN                Based on a review of historic packaging validations; it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity.  This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray; resulted in failure

Asante Solutions; Inc.    Dec-27-2013       Asante Comfort Infusion Set – Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs; singles;or inside a Combination Kit (FG-5123-4)Manufactured for:Asante SolutionsSunnyvale; CA;Manufactured by:UnomedicalLejre; Denmark   Reports of the infusion tubing disconnecting from the connector; resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.

Zimmer; Inc.       Dec-27-2013       TIB NAIL – TIB NAIL          Based on a review of historic packaging validations; it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity.  This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray; resulted in failure

Zimmer; Inc.       Dec-27-2013       DIST LAT FEM LOCK PLT; LT – DIST LAT FEM LOCK PLT; LT Based on a review of historic packaging validations; it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity.  This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray; resulted in failure

Zimmer; Inc.       Dec-27-2013       TIBIO FEM/FEM NAIL – TIBIO FEM/FEM NAIL.      Based on a review of historic packaging validations; it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity.  This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray; resulted in failure

Zimmer; Inc.       Dec-27-2013       NGK Stem Ext 24 x 245mm – NGK Stem Ext 24 x 245mm  Based on a review of historic packaging validations; it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity.  This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray; resulted in failure

Integra LifeSciences Corp.            Dec-27-2013       Integra – Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences; 311 Enterprise Dr Plainsboro; NJ 08536 USAThe Camino Advanced Monitor is a compact; portable device for use with Camino 110-4 series of Pressure / Temperature and Pressure Transducer-Tipped Catheters. Pressure and/or Temperature are measured at the Catheter tip; eliminating the need for external transducers; fluid; pressure tubing; and flush devices. The Camino displays intracranial pressure (ICP); intracranial temperature (ICT); and calculates cerebral perfusion pressure (CPP) (CPP = mean arterial pressure – mean intracranial pressure). The Camino provides a continuous display of the ICP waveform; as well as mean ICP; CPP; ICT; or systolic and diastolic waveform values. A continuous record of mean pressure and CPP values over the most recent 24-hour period is stored in memory; and can be displayed on command as a TREND either as the most recent 12 or 24 hour period. Outputs for ICP and ICT are available for use with patient bedside monitors. An isolated analogue output provides a continuous ICP waveform for hard copy documentation or data acquisition. An input to receive mean arterial pressure from a compatible patient bedside monitor is available for use when it is desired to have a CPP reading. The mean arterial pressure cannot be acquired from a non-invasive blood pressure cuff. Although the Camino is intended to be a stand-alone system; it also conveniently connects to hospital bedside monitoring systems.    Integra became aware through a complaint from a single non-US customer that if the optional SYS/DIAS mode is used on CAM01 monitor that contains Mod 4 Firmware; the displayed values for the systolic and diastolic intracranial pressure (ICP) are reversed.  But; if the CAM01 is used with an auxiliary bedside monitor; the bedside monitor displays these values correctly.

Asante Solutions; Inc.    Dec-27-2013       Asante Conset Infusion Set – Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs;singles; or inside a Combination Kit (FG-5229-4);Distributed by Asante Solutions;Sunnyvale; CA;Manufactured by Convatec;Lejre; Denmark.                Reports of the infusion tubing disconnecting from the connector; resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.

Asante Solutions; Inc.    Dec-27-2013       Asante Conset Infusion Set – Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs;singles;or inside a Combination Kit (FG-5249-4)Distributed by Asante Solutions;Sunnyvale; CA;Manufactured by Convatec;Lejre; Denmark.                Reports of the infusion tubing disconnecting from the connector; resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.

Asante Solutions; Inc.    Dec-27-2013       Asante Comfort Infusion Set – Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs;singles; or inside a Combination Kit (FG-5143-4).Manufactured for:Asante SolutionsSunnyvale; CA;Manufactured by:UnomedicalLejre; Denmark   Reports of the infusion tubing disconnecting from the connector; resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.

Asante Solutions; Inc.    Dec-27-2013       Asante Conset Infusion Set – Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs; singles;or inside a Combination Kit (FG-5246-4)Distributed by Asante Solutions;Sunnyvale; CA;Manufactured by Convatec;Lejre; Denmark.                Reports of the infusion tubing disconnecting from the connector; resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.

Terumo Cardiovascular Systems Corporation      Dec-27-2013       Terumo Cardiovacular – Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve; LN130B; in the Arterial Recirculation Line                Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.

Philips Medical Systems; Inc.      Dec-27-2013       Philips Healthcare – Philips HeartStart MRx Monitor/DefibrillatorModels: M3536A Options A20 – A27; HeartStart MRx ALSMonitor (Grey)The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support; advanced cardiac support; or defibrillation. It must be used by or on the order of a physician    Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monitor/Defibrillators.   The first energy setting is labeled 10 when it should be labeled1-10

Steris Corporation           Dec-28-2013       VERIFY Dual Species Self-Contained Biological Indicator – VERIFY Dual Species Self-Contained Biological Indicator; Distributed by STERIS Corporation; Mentor; OH.Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.       STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Contained Biological Indicators.  As a result the spore count on the affected product is lower than the labeled minimum and the product may incorrectly indicate that a 5-log spore kill was achieved.

Advanced Sterilization Products                Dec-28-2013       STERRAD Cyclesure Biological Indicator – STERRAD Cyclesure Biological Indicator (BI; Part No. 14324.Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.          Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in the outer vial of the STERRAD Cyclesure 24 Biological Indicator.

Baxter Healthcare Corp.                Dec-29-2013       IntelliFill i.v. Pharmacy Compounding Device (PCD) – IntelliFill i.v. Pharmacy Compounding Device (PCD).Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders.              Following a retrospective review for Baxter Daytona Complaint CR-954; it was identified that the IntelliFill i.v. Pharmacy Compounding Device (PCD) (product code: IFIV) has the potential to continue to run and fill syringes with the HEPA filtration disabled.

Instrumentation Industries Inc  Dec-29-2013       RTC 25-C Inline Aerosol Tee Adapter – RTC 25-C Inline Aerosol Tee Adapter.Intended to be used to adapt an aerosolized medication delivery system having an elliptical mouthpiece to a ventilator circuit.              Some packages of the RTC 25-C may have been shipped to customers with incomplete Installation and Usage Directions due to a printing error.

Zimmer; Inc.       Dec-30-2013       Trabecular Metal ( TM) – Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative; rheumatoid; or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661               Zimmer is initiating a lot specific recall of the CPT Hip Stem; Versys Build-Up Block; and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct.

Zimmer; Inc.       Dec-30-2013       Versys Build-Up Block – Versys Build-Up BlockThe VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by defi ciencies of the femoral head; neck; or portions of the proximal femur. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief and when there is progressive disability.    Zimmer is initiating a lot specific recall of the CPT Hip Stem; Versys Build-Up Block; and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct.

Zimmer; Inc.       Dec-30-2013       CPT Hip System – CPT Hip System; Parts 00-8114-002-10 and 00-8011-004-00Hip joint metal/polymer semi-constrained cemented prosthesis.The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; collagen disorders; avascular necrosis of the femoral head; and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia; protrusio acetabuli; or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures. 510(k) K960658         Zimmer is initiating a lot specific recall of the CPT Hip Stem; Versys Build-Up Block; and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct.

Copyright © 2020 · WTWH Media LLC and its licensors. All rights reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

25mm Galvanized Wire Buckles

Steel Strip, Steel Packing Strap, Galvanized Steel Strip, Iron Packing Strip - JinHe Metal,https://www.jinhejinshu.com/