Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0478-2012 | Baxter Interlink System Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites... | Baxter Healthcare Corporation | FMG | ||
| Z-0477-2012 | Baxter Interlink System Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites... | Baxter Healthcare Corporation | FMG | ||
| Z-0476-2012 | Baxter Interlink System 3-Port Manifold with Check Valves, Vol. 1.0 mL, Large Bore 4-Way... | Baxter Healthcare Corporation | FMG | ||
| Z-0475-2012 | Baxter Interlink System Extension Set, 13" (32 cm), Check Valve, Injection Site, Male... | Baxter Healthcare Corporation | FPA | ||
| Z-0474-2012 | Baxter Interlink System Continu-Flo Solution Set with Control-A-Flo Regulator, 89" (2.3... | Baxter Healthcare Corporation | FPA | ||
| Z-0473-2012 | Baxter Interlink System Y-Type Solution Set, 78" (2.0 m), 2 Injection Sites, Male Luer... | Baxter Healthcare Corporation | FPA | ||
| Z-0472-2012 | Baxter Interlink System Vented Continu-Flo Solution Set, 100" (2.5 m), Vol. 2.9 mL, 3... | Baxter Healthcare Corporation | FPA | ||
| Z-0471-2012 | Baxter Interlink System Extension Set, 20" (51 cm), Vol. 2.9 mL, Injection Site, Male... | Baxter Healthcare Corporation | FPA | ||
| Z-0470-2012 | Baxter Interlink System Continu-Flo Solution Set, 69" (1.8 m), 2 Injection Sites, Male... | Baxter Healthcare Corporation | FMG | ||
| Z-0469-2012 | Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male... | Baxter Healthcare Corporation | FMG | ||
| Z-0739-2012 | VenaCureEVLT Perforator Vein Ablation Kit, CATALOG #: EVLT/PVAK, STERILE -- Manufactured... | Angiodynamics Worldwide Headquarters | GEX | ||
| Z-0675-2012 | CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter... | Terumo Cardiovascular Systems Corporation | DRY | ||
| Z-0674-2012 | CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter... | Terumo Cardiovascular Systems Corporation | DRY | ||
| Z-0673-2012 | CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter... | Terumo Cardiovascular Systems Corporation | DRY | ||
| Z-0672-2012 | CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter... | Terumo Cardiovascular Systems Corporation | DRY | ||
| Z-2270-2012 | Class II | Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry | CliniSys, Inc | JQP | |
| Z-0643-2012 | Neulook Deluxe is packaged in a pink soft plastic box with white, black, and rainbow... | Eyezone | LPL | ||
| Z-0642-2012 | Neulook Fancy FX is packaged in a small glass bottle with a orange, white, and yellow... | Eyezone | LPL | ||
| Z-0467-2012 | MORPHEUS CT PICC with STYLET, 5F Dual Lumen 65 cm Insertion Kit, Catalog No./REF 1200923... | Angiodynamics Worldwide Headquarters | LJS | ||
| Z-0509-2012 | Benephit XT Infusion System, Targeted Renal Therapy Infusion System, Catalog/REF 70035... | Angiodynamics Worldwide Headquarters | KRA | ||
| Z-1060-2012 | Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System"). Head sizes... | Ascension Orthopedics, Inc. | KXE | ||
| Z-1391-2012 | EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0805-2012 | GEMINI TF 16 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model # 882470 &... | Philips North America LLC | KPS | ||
| Z-0771-2012 | PTS Heart/Lung Perfusion Pack Labeling Sterile EO, Product is manufactured by Sorin Group... | LivaNova USA, Inc. | DTZ | ||
| Z-0770-2012 | Synthesis PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by... | LivaNova USA, Inc. | DTZ | ||
| Z-0769-2012 | SYNERGY Perfusion Tubing Systems US Denver PHISIO, Sorin Group USA, Tubing set heart-lung... | LivaNova USA, Inc. | KFM | ||
| Z-0768-2012 | PRIMO2X Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin... | LivaNova USA, Inc. | DTZ | ||
| Z-0767-2012 | D 905 EOS Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin... | LivaNova USA, Inc. | DTZ | ||
| Z-0766-2012 | D 903 Avant Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin... | LivaNova USA, Inc. | DTZ | ||
| Z-0765-2012 | Apex HP PHisio SMART Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S... | LivaNova USA, Inc. | DTZ | ||
| Z-0764-2012 | Apex HP PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by... | LivaNova USA, Inc. | DTZ | ||
| Z-0763-2012 | Apex HP Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin... | LivaNova USA, Inc. | DTZ | ||
| Z-0762-2012 | Apex Phisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin... | LivaNova USA, Inc. | DTZ | ||
| Z-0761-2012 | Apex SMART PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by... | LivaNova USA, Inc. | DTZ | ||
| Z-0760-2012 | Apex Oxygenator, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th... | LivaNova USA, Inc. | DTZ | ||
| Z-0517-2012 | Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog numbers... | Teleflex Medical | BSR | ||
| Z-1243-2012 | COULTER LH 500 Series System , part number: LH500 System Help 2A4.103271; LH 500... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1242-2012 | COULTER LH 750 Analyzer, part number: LH750 System Help 2D1.103272, PN 6605632, PN... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1241-2012 | COULTER LH 780 Analyzer, part number: LH780 System Help 1B1.103272, PN 723585. SW... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1350-2012 | Oridion Surestream CO2 Sampling Lines- Sure VentLine H Set Adult/Pediatric Part Number... | Oridion Medical 1987 Ltd. | CCK | ||
| Z-1349-2012 | Oridion Surestream CO2 Sampling Lines- Sure VentLine Set Adult/Pediatric Part Number... | Oridion Medical 1987 Ltd. | CCK | ||
| Z-1348-2012 | Oridion Surestream CO2 Sampling Lines- SureLine O2 Part Number: 010979-03 Product... | Oridion Medical 1987 Ltd. | CCK | ||
| Z-1347-2012 | Oridion Surestream CO2 Sampling Lines- Smart SureLine Plus O2 adult Part Number... | Oridion Medical 1987 Ltd. | CCK | ||
| Z-1346-2012 | Oridion Surestream CO2 Sampling Lines- SureLine Adult Part Number: 010976-03 Product... | Oridion Medical 1987 Ltd. | CCK | ||
| Z-0734-2012 | Outer Carton labeled in part:" 1-DAY ACUVUE MOIST BRAND CONTACT LENSES WITH LACREON FOR... | Johnson & Johnson Vision Care, Inc. | MVN | ||
| Z-0798-2012 | Mevatron KDS-2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0797-2012 | Mevatron KD-2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0796-2012 | Mevatron KDS-2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0795-2012 | Mevatron MD-2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0794-2012 | Mevatron M2 6740; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and... | Siemens Medical Solutions USA, Inc. | IYE |