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Cook Inc.

380 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous recall (Z-1186-2011)Cook, Inc.2011-02-23
Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous recall (Z-1187-2011)Cook, Inc.2011-02-23
Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous recall (Z-1188-2011)Cook, Inc.2011-02-23
Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous recall (Z-1189-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Ca recall (Z-1190-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Ca recall (Z-1191-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Ca recall (Z-1192-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Ca recall (Z-1193-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Ca recall (Z-1194-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Ca recall (Z-1195-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Ca recall (Z-1196-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Ca recall (Z-1197-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Ca recall (Z-1198-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Ca recall (Z-1199-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Ca recall (Z-1200-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Ca recall (Z-1201-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Ca recall (Z-1202-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Ca recall (Z-1203-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Ca recall (Z-1204-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Ca recall (Z-1205-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Ca recall (Z-1206-2011)Cook, Inc.2011-02-23
Central Venous Catheter Tray Five Lumen Polyurethane, 10.0 Fr/ 20cm, C-UQLMY-1001J-RSC-CCT recall (Z-1207-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lume recall (Z-1208-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen Polyurethan recall (Z-1209-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen Polyurethan recall (Z-1210-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen Polyurethan recall (Z-1211-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen Polyurethan recall (Z-1212-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen Polyurethan recall (Z-1213-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Ca recall (Z-1214-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Ca recall (Z-1215-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Ca recall (Z-1216-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Ca recall (Z-1217-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Ca recall (Z-1218-2011)Cook, Inc.2011-02-23
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PT recall (Z-2076-2010)Cook, Inc.2010-07-26
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PT recall (Z-2077-2010)Cook, Inc.2010-07-26
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PT recall (Z-2078-2010)Cook, Inc.2010-07-26
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PT recall (Z-2079-2010)Cook, Inc.2010-07-26
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PT recall (Z-2080-2010)Cook, Inc.2010-07-26
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PT recall (Z-2081-2010)Cook, Inc.2010-07-26
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PT recall (Z-2082-2010)Cook, Inc.2010-07-26
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PT recall (Z-2083-2010)Cook, Inc.2010-07-26
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PT recall (Z-2084-2010)Cook, Inc.2010-07-26
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PT recall (Z-2085-2010)Cook, Inc.2010-07-26
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PT recall (Z-2086-2010)Cook, Inc.2010-07-26
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G36116, C-PTB recall (Z-2087-2010)Cook, Inc.2010-07-26
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G36118, C-PTB recall (Z-2088-2010)Cook, Inc.2010-07-26
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G51971, C-PTB recall (Z-2089-2010)Cook, Inc.2010-07-26
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G36117, C-PTB recall (Z-2090-2010)Cook, Inc.2010-07-26
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G49507, C-PTB recall (Z-2091-2010)Cook, Inc.2010-07-26
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G51972, C-PTB recall (Z-2092-2010)Cook, Inc.2010-07-26
Cook Hilal Embolization Microcoil, 3 mm, sterile. The device is an intravascular implant i recall (Z-2057-2008)Cook, Inc.2008-09-16
Cook Hilal Embolization Microcoil, 6 mm, sterile. The device is an intravascular implant i recall (Z-2058-2008)Cook, Inc.2008-09-16
Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM l recall (Z-0892-2008)Cook, Inc.2008-04-16
Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 15.5 CM l recall (Z-0893-2008)Cook, Inc.2008-04-16
Peel-Away Introducer set, Catheter introducer, sterile; Catalog Number: C-PLI-7.0-38-CPC-0 recall (Z-0894-2008)Cook, Inc.2008-04-16
Minipuncture Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 F recall (Z-0895-2008)Cook, Inc.2008-04-16
Peel-Away Introducer set, 7.0 FR; includes sheath: 7.0 FR., Catheter introducer, 9 CM long recall (Z-0896-2008)Cook, Inc.2008-04-16
Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM l recall (Z-0897-2008)Cook, Inc.2008-04-16
Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM l recall (Z-0898-2008)Cook, Inc.2008-04-16
Peel-Away Introducer set without wire guide, 7.0 FR X 15.5 CM. Catheter introducer, Accept recall (Z-0899-2008)Cook, Inc.2008-04-16
Peel-Away Introducer set without wire guide, 7.0 FR X 15.5 CM. Catheter introducer, Accept recall (Z-0900-2008)Cook, Inc.2008-04-16
Cook TPN Double Lumen Catheter set; Catheter introducer, includes 6.0 FRENCH, 65 CM Silico recall (Z-0901-2008)Cook, Inc.2008-04-16
Cook TPN Single Lumen Catheter set; Catheter introducer, includes 6.5 FRENCH, 90 CM Silico recall (Z-0902-2008)Cook, Inc.2008-04-16
Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 15.5 CM l recall (Z-0903-2008)Cook, Inc.2008-04-16
Catalog Number: C-TPNS-6.5-90-REDO+. Catheter introducer, Note: This product is not distri recall (Z-0904-2008)Cook, Inc.2008-04-16
THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff cat recall (Z-0135-2008)Cook, Inc.2008-02-06
Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, infl recall (Z-0665-2007)Cook, Inc.2007-03-29
COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum Glide Antimicrobial Cath recall (Z-0637-2007)Cook, Inc.2007-03-16
Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diame recall (Z-0080-2007)Cook, Inc.2006-10-28
Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diame recall (Z-0600-06)Cook, Inc.2006-03-09
Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent recall (Z-0390-06)Cook, Inc.2006-01-13
Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent recall (Z-0391-06)Cook, Inc.2006-01-13
Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038'' (0.97 mm) recall (Z-0368-06)Cook, Inc.2006-01-10
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System recall (Z-0498-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0499-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0500-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0501-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0502-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0503-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0504-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0505-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0506-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0507-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0508-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0509-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0510-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0511-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0512-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0513-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0514-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0515-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0516-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0517-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0518-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0519-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0520-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0521-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0522-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0523-05)Cook, Inc.2005-02-03
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0524-05)Cook, Inc.2005-02-03
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