Medical Device Recalls

CFRES ID Product Res No Recall Status Product Code Event Date Initiated Recalling Firm Product Description
67392 Z-0983-2008 Terminated CBK 2007-12-17 Viasys Respiratory Care, Inc.dba Bird Products VIASYS AVEA Ventilator, Catalog numbers: 17210-03 (Italian Comprehensive Version)
67152 Z-0987-2008 Terminated BZD 2008-01-04 Cardinal Health AirLife Infant nCPAP System Driver (Catalog No: 006900;) a nasal continuous positive airway pressure device, which is part of a larger system that includes an Infant Nasal CPAP generator, fixation device and patient interface (prongs and/or mask); Cardinal Health, McGaw Park, IL 60085
69047 Z-1401-2008 Terminated IYE 2008-01-11 Siemens Medical Solutions USA, Inc Mevatron KD-2 Medical Linear Accelerator, Material Number: 8515520, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA
69279 Z-1388-2008 Terminated NZW 2008-02-28 Baxter Healthcare Corp. Rt. Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-2 mL vial, 25 pack, NDC 0641-0387-25, (NDC 0641-0387-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
66632 Z-1115-2008 Terminated CKA 2007-12-14 Pointe Scientific, Inc. Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 7-A7526-R1-120, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188.
67336 Z-1241-2008 Terminated LLZ 2007-06-21 AGFA Corp. Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Westerly, Rhode Island 02891. The software is used in the Agfa HeartLab Cardiovascular System.
66961 Z-1161-2008 Terminated MSX 2007-12-13 GE Healthcare S/5 iCentral, Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and L-NETC05, GE Healthcare, Wauwatosa, WI 53226.
69669 Z-1644-2008 Terminated LLZ 2008-01-01 Emageon EVMS (Enterprise Visual Medical System); Picture archiving and communications system; Model Numbers: 5.30.4, 5.30.5, 5.30.6, 5.30.7, 5.40.0 and 7.0.0.1. Emageon, Inc., Hartland, WI 53029.
69274 Z-1630-2008 Terminated MLR 2008-02-25 Advanced Sterilization Products STERRAD 200 Sterilization System, Product Code 10201 Used to sterilize heat and moisture sensitive reusable medical devices.
67307 Z-1529-2008 Terminated GKZ 2007-08-20 Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
69276 Z-1631-2008 Terminated MLR 2008-02-25 Advanced Sterilization Products STERRAD NX Sterilizer, Product Code 10033 Used to sterilize heat and moisture sensitive reusable medical devices.
68274 Z-1238-2008 Terminated DQA 2008-02-13 International Technidyne Corp. International Technidyne Corp. (ITC) AVOXimeter 1000E Oximeter, Catalog Numbers: AVOX1000E-110 and AVOX1000E-220
68020 Z-1294-2008 Terminated FGE 2007-12-05 Edwards Lifesciences, Llc Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070201CD; Edwards Lifesciences LLC, Irvine, CA 92614.
67916 Z-1248-2008 Terminated FGE 2007-12-05 Edwards Lifesciences, Llc Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060803CD; Edwards Lifesciences LLC, Irvine, CA 92614.
68019 Z-1293-2008 Terminated FGE 2007-12-05 Edwards Lifesciences, Llc Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090203CD; Edwards Lifesciences LLC, Irvine, CA 92614.
67929 Z-1259-2008 Terminated FGE 2007-12-05 Edwards Lifesciences, Llc Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060303CD; Edwards Lifesciences LLC, Irvine, CA 92614.
67994 Z-1275-2008 Terminated FGE 2007-12-05 Edwards Lifesciences, Llc Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080801CD; Edwards Lifesciences LLC, Irvine, CA 92614.
68016 Z-1290-2008 Terminated FGE 2007-12-05 Edwards Lifesciences, Llc Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090201CD; Edwards Lifesciences LLC, Irvine, CA 92614.
69049 Z-1381-2008 Terminated JWH 2005-02-08 Stryker Howmedica Osteonics Corp. Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 70-300-7R; Stryker Corp, Howmedica Osteonics Corp, Mahwah, NJ 07430.
69050 Z-1382-2008 Terminated JWH 2005-02-08 Stryker Howmedica Osteonics Corp. Scorpio Total Knee Posteriorly Stabilized Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 71-4507R; Stryker Corp, Howmedica Osteonics Corp, Mahwah, NJ 07430.
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