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Cook Inc.

380 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor I recall (Z-0591-2021)Cook Inc.2020-12-23
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234 Flexor I recall (Z-0592-2021)Cook Inc.2020-12-23
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 Flexor I recall (Z-0593-2021)Cook Inc.2020-12-23
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 Flexor I recall (Z-0594-2021)Cook Inc.2020-12-23
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 Flexor I recall (Z-0595-2021)Cook Inc.2020-12-23
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor I recall (Z-0596-2021)Cook Inc.2020-12-23
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor I recall (Z-0597-2021)Cook Inc.2020-12-23
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor I recall (Z-0598-2021)Cook Inc.2020-12-23
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor I recall (Z-0599-2021)Cook Inc.2020-12-23
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor I recall (Z-0600-2021)Cook Inc.2020-12-23
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor I recall (Z-0601-2021)Cook Inc.2020-12-23
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 Flexor I recall (Z-0602-2021)Cook Inc.2020-12-23
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor I recall (Z-0603-2021)Cook Inc.2020-12-23
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 Flexor I recall (Z-0604-2021)Cook Inc.2020-12-23
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor I recall (Z-0605-2021)Cook Inc.2020-12-23
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor I recall (Z-0606-2021)Cook Inc.2020-12-23
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor I recall (Z-0607-2021)Cook Inc.2020-12-23
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor I recall (Z-0608-2021)Cook Inc.2020-12-23
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor I recall (Z-0609-2021)Cook Inc.2020-12-23
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-H recall (Z-0610-2021)Cook Inc.2020-12-23
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-H recall (Z-0611-2021)Cook Inc.2020-12-23
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide w recall (Z-0399-2021)Cook Inc.2020-11-03
Pressure Monitoring Set, C-PMS, G02838 recall (Z-2203-2020)Cook Inc.2020-06-02
Pressure Monitoring Tray, C-PMSY, G02854 recall (Z-2204-2020)Cook Inc.2020-06-02
Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascula recall (Z-1355-2020)Cook Inc.2020-01-31
CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnosti recall (Z-0587-2020)Cook Inc.2019-12-09
CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnosti recall (Z-0588-2020)Cook Inc.2019-12-09
CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnost recall (Z-0589-2020)Cook Inc.2019-12-09
CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnost recall (Z-0590-2020)Cook Inc.2019-12-09
Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-11 recall (Z-1844-2019)Cook Inc.2019-06-19
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number A recall (Z-1756-2019)Cook Inc.2019-06-17
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number A recall (Z-1757-2019)Cook Inc.2019-06-17
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number recall (Z-1758-2019)Cook Inc.2019-06-17
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transsept recall (Z-0979-2019)Cook Inc.2019-03-13
Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage: The connecting recall (Z-1751-2018)Cook Inc.2018-05-09
Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The connect recall (Z-1752-2018)Cook Inc.2018-05-09
Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM Product Usage: The connecting recall (Z-1753-2018)Cook Inc.2018-05-09
Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting recall (Z-1754-2018)Cook Inc.2018-05-09
Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage: The connecting recall (Z-1755-2018)Cook Inc.2018-05-09
Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting recall (Z-1756-2018)Cook Inc.2018-05-09
MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocess recall (Z-1377-2018)Cook Inc.2018-04-13
MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor recall (Z-1378-2018)Cook Inc.2018-04-13
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-ope recall (Z-2539-2017)Cook Inc.2017-06-05
Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber recall (Z-2540-2017)Cook Inc.2017-06-05
Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set recall (Z-1870-2017)Cook Inc.2017-04-19
Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray C recall (Z-0733-2017)Cook Inc.2016-12-12
Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; recall (Z-2537-2016)Cook Inc.2016-08-25
Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic recall (Z-2610-2016)Cook Inc.2016-08-22
Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The cat recall (Z-2611-2016)Cook Inc.2016-08-22
Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip V recall (Z-2612-2016)Cook Inc.2016-08-22
Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended fo recall (Z-2613-2016)Cook Inc.2016-08-22
Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intend recall (Z-2614-2016)Cook Inc.2016-08-22
FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used f recall (Z-2615-2016)Cook Inc.2016-08-22
Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for trans recall (Z-2616-2016)Cook Inc.2016-08-22
Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination w recall (Z-2617-2016)Cook Inc.2016-08-22
Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver h recall (Z-2618-2016)Cook Inc.2016-08-22
Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture recall (Z-2619-2016)Cook Inc.2016-08-22
Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-punctur recall (Z-2620-2016)Cook Inc.2016-08-22
Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector, Uterine recall (Z-2621-2016)Cook Inc.2016-08-22
Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access recall (Z-2622-2016)Cook Inc.2016-08-22
White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of a recall (Z-2623-2016)Cook Inc.2016-08-22
UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radio recall (Z-1237-2016)Cook Inc.2016-03-24
Ascend AQ Ureteral Dilation Balloon Catheter Set The Ascend AQ Ureteral Dilation Balloon C recall (Z-1238-2016)Cook Inc.2016-03-24
Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle cons recall (Z-1028-2016)Cook Inc.2016-02-29
Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedur recall (Z-0798-2016)Cook Inc.2016-02-24
Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are compris recall (Z-0799-2016)Cook Inc.2016-02-24
Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised o recall (Z-0800-2016)Cook Inc.2016-02-24
Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are recall (Z-0801-2016)Cook Inc.2016-02-24
Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are c recall (Z-0802-2016)Cook Inc.2016-02-24
VentriClear II Ventricular Drainage Catheter Set. Allows external access and drainage of c recall (Z-0416-2016)Cook Inc.2015-12-14
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for c recall (Z-0244-2016)Cook Inc.2015-11-06
Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic pr recall (Z-2317-2015)Cook Inc.2015-08-05
Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiogra recall (Z-2318-2015)Cook Inc.2015-08-05
Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures a recall (Z-2319-2015)Cook Inc.2015-08-05
Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepati recall (Z-2100-2015)Cook Inc.2015-07-18
Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for recall (Z-2101-2015)Cook Inc.2015-07-18
LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouc recall (Z-1830-2015)Cook Inc.2015-06-24
CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film steriliza recall (Z-2243-2014)Cook Inc.2014-08-27
Zilver PTX Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: recall (Z-1274-2013)Cook, Inc.2013-05-15
Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage recall (Z-1275-2013)Cook, Inc.2013-05-15
Sydney IVF Culture Oil, REF, K- SICO- 50, 50 mL. and K-SICO-200, 200 mL,Store at 2-8 C, St recall (Z-1324-2012)Cook, Inc.2012-03-28
Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-24-82-ZT, REF G48407, recall (Z-3130-2011)Cook, Inc.2011-09-06
Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-24-96-ZT, REF G48408, recall (Z-3131-2011)Cook, Inc.2011-09-06
Cook Medical, Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-26-96-ZT, REF G48413, recall (Z-3132-2011)Cook, Inc.2011-09-06
Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-26-125-ZT, REF G48415, recall (Z-3133-2011)Cook, Inc.2011-09-06
Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-28-96-ZT, REF G48418, recall (Z-3134-2011)Cook, Inc.2011-09-06
Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-30-82-ZT, REF G48422, recall (Z-3135-2011)Cook, Inc.2011-09-06
Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-32-82-ZT, REF G48427, recall (Z-3136-2011)Cook, Inc.2011-09-06
Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-32-96-ZT, REF G48428, recall (Z-3137-2011)Cook, Inc.2011-09-06
Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-36-95-ZT, REF G48432, recall (Z-3138-2011)Cook, Inc.2011-09-06
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-10-71-ZT, REF G48444, recall (Z-3139-2011)Cook, Inc.2011-09-06
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-12-56-ZT, REF G48449, recall (Z-3140-2011)Cook, Inc.2011-09-06
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-14-56-ZT, REF G48455, recall (Z-3141-2011)Cook, Inc.2011-09-06
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-56-ZT, REF G48461, recall (Z-3142-2011)Cook, Inc.2011-09-06
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-73-ZT, REF G48462, recall (Z-3143-2011)Cook, Inc.2011-09-06
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-90-ZT, REF G48463, recall (Z-3144-2011)Cook, Inc.2011-09-06
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-18-56-ZT, REF G48465, recall (Z-3145-2011)Cook, Inc.2011-09-06
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-18-73-ZT, REF G48466, recall (Z-3146-2011)Cook, Inc.2011-09-06
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48469, recall (Z-3147-2011)Cook, Inc.2011-09-06
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-73-ZT, REF G48470, recall (Z-3148-2011)Cook, Inc.2011-09-06
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