Medical Device Recalls

CFRES ID Product Res No Recall Status Product Code Event Date Initiated Recalling Firm Product Description
67942 Z-1124-2008 Terminated FGE 2008-01-18 ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-16, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-1431-000. ev3 IntraStent LD DoubleStrut Large Diameter Peripheral Stent, Model Number: S15-16, Catalog Number: 90-1504-000 (not approved within USA).
67232 Z-0994-2008 Terminated HBE 2008-01-10 Stryker Instruments Div. of Stryker Corporation Stryker 12.3 x 10.7 mm Fluted Drum, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-20-123.
66509 Z-1074-2008 Terminated BZD 2007-10-15 Respironics, Inc. Power Supply under the following brand names: a) RP, Power Supply Assembly model number H3600-015, and b) RP, Wiring Harness, Lamp Holder model number H3600-020. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
66516 Z-1081-2008 Terminated BZD 2007-10-15 Respironics, Inc. RP Duet LX/Pro Out Port w/Seal model number 622239. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
66517 Z-1082-2008 Terminated CBK 2007-10-15 Respironics, Inc. RP-Leaf, Check valve-5 pk model number F33440. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
66507 Z-1072-2008 Terminated BZD 2007-10-15 Respironics, Inc. RP M Series Pollen Filter Kit 1 pack model number 1035443. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
67238 Z-1000-2008 Terminated HBE 2008-01-10 Stryker Instruments Div. of Stryker Corporation Stryker Tapered Router Extra Long (2.3mm x 22.0mm) for use with extra long "R" Attachments, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-71-223.
67239 Z-1001-2008 Terminated HBE 2008-01-10 Stryker Instruments Div. of Stryker Corporation Stryker 2.0 mm x 3.8 mm Neuro Drill, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-107-30.
66522 Z-1085-2008 Terminated CBK 2007-10-15 Respironics, Inc. Continuous ventilator accessories under the following brand names: a) RP-Seal, Spring-5 pk model number F35465; b) RP-Seal, Greece, Ballscrew model number F35036; c) RP-Tub PVC 1/8 in x ¿ 50 ft model number 1008841; d) RP-Vision Filter Cover model number 1003444; e) RP-Vision RS-232 HRN ABV 106K model number 1004699; and f) RP-Wrap, Cord model number F35195. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
66494 Z-1060-2008 Terminated CBK 2007-10-15 Respironics, Inc. Mouthpiece, Angled 22mm CE model number FC06566. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
66523 Z-1086-2008 Terminated NPF 2007-10-15 Respironics, Inc. APNEA monitor accessories under the following brand names: a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL model number 1025422; b) SM 2/2 PS Europe Patient Cable, Metal model number 1030194; and c) Smartmonitor 2 with modem, PCMCIA model number 4003. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
66504 Z-1069-2008 Terminated BZD 2007-10-15 Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) REMStar Pro2 Domestic model number 1020923; b) REMStar Pro M, w/Humid w/Smartcard US model number DS400HS; c) REMStar Pro M w/Smartcard US model number DS400S; d) REMStar Pro/Plus Silencer Cap model number 1005962; e) REMStar Pro/Plus/Auto/Lite Pollen model number 1005964; f) REMStar Pro/Plus/Auto/Lite Pollen SNGL model number 1001389; g) REMStar Pro/Plus/Auto/Lite Ultrafine model number 1005945; and h) REMStar Pro/Plus/Auto/Lite Ultrafine Qty 1 model number 1039607. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
67249 Z-1011-2008 Terminated HBE 2008-01-10 Stryker Instruments Div. of Stryker Corporation Stryker 5.0 mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-150.
69114 Z-1457-2008 Terminated GCY 2008-01-31 Zimmer Inc. Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number; 47-2550-003-10; 400 ml evacuators and 450 ml collection bags, 3/16 in. (15 FR.) O.D. middle perforated PVC drains with trocars, evaluator tubing and connectors, soft, contains 10, non-sterile, latex free, Zimmer, Dover, Ohio
67039 Z-0585-2008 Terminated GEX 2007-12-18 Lumenis, Inc. Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In Israel, Manufactured By LUMENIS, P.O.Box 240, Yokneam, ISRAEL.
69106 Z-1449-2008 Terminated GCY 2008-01-31 Zimmer Inc. Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/ REF 00-2550-002-10, 400 ml-INF. Cntrl. Kit w/ 1/8" drain, 3.2 mm, 10Fr, PVC, 107 cm, medium, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio
67194 Z-0912-2008 Terminated EZN 2007-11-30 Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog Number: 255107; Product Number: M0062551070, Onset Medical, Boston Scientific Corp., Natick, MA 01760
67211 Z-1106-2008 Terminated JDZ 2008-01-10 Stryker Instruments Div. of Stryker Corporation Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Stryker Instruments, Kalamazoo, MI 49001.
67280 Z-1038-2008 Terminated LLZ 2007-12-21 Siemens Medical Solutions USA, Inc Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Siemens Medical Solutions, Inc., Malvern, PA 19355
67218 Z-0915-2008 Terminated FMF 2008-01-07 Becton Dickinson & Company BD 10 ml Syringe Luer Lok Tip, Reorder #3039605, BD, Franklin Lakes, NJ 07417.
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