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Cook Inc.

FDA Regulatory Profile

Summary

Total Recalls
264 (42 Class I)
510(k) Clearances
190
Inspections
4
Compliance Actions
0

Known Names

cook, cook pacemaker, cook endoscopy, cook ireland, cook biotech, cook medical incorporated, cook incorporated

Recent Recalls

NumberClassProductDate
Z-0388-2022Class IIFlexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order NumNovember 12, 2021
Z-0387-2022Class IIFlexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order NuNovember 12, 2021
Z-0414-2022Class IISkinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available wOctober 13, 2021
Z-0223-2022Class IITransseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting ofOctober 8, 2021
Z-0222-2022Class IITransseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consistsOctober 8, 2021
Z-0185-2022Class IIFlexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheatSeptember 28, 2021
Z-0186-2022Class IIFlexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN GSeptember 28, 2021
Z-0960-2021Class IICook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection durJanuary 4, 2021
Z-0601-2021Class IFlexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor IntroduNovember 24, 2020
Z-0594-2021Class IFlexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 Flexor IntroduNovember 24, 2020
Z-0593-2021Class IFlexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 Flexor IntroduNovember 24, 2020
Z-0598-2021Class IFlexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor IntroduNovember 24, 2020
Z-0600-2021Class IFlexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor IntroduNovember 24, 2020
Z-0605-2021Class IFlexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor IntroduNovember 24, 2020
Z-0609-2021Class IFlexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor IntroduNovember 24, 2020
Z-0591-2021Class IFlexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor IntroduNovember 24, 2020
Z-0604-2021Class IFlexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 Flexor IntroduNovember 24, 2020
Z-0610-2021Class IFlexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order NNovember 24, 2020
Z-0607-2021Class IFlexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor IntroduNovember 24, 2020
Z-0596-2021Class IFlexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor IntroduNovember 24, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K133130BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETERJanuary 9, 2015
K140593ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDEDecember 15, 2014
K132592FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SETOctober 9, 2014
K133597CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY April 18, 2014
K131772CANTATA(R) 2.9 MICROCATHETERFebruary 20, 2014
K131204ADVANCE CS CORONARY SINUS INFUSION CATHETERJanuary 29, 2014
K133634SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SETDecember 23, 2013
K132020ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETEROctober 25, 2013
K131201ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE October 7, 2013
K131206COOK CERVICAL RIPENING BALLOONSeptember 27, 2013
K132334TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SETAugust 16, 2013
K122091COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSISJuly 29, 2013
K130766ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDEJuly 17, 2013
K122917CODA BALLOON CATHETERJune 28, 2013
K130293ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETERMay 31, 2013
K130444H-30 HOLMIUM LASER SYSTEMMay 22, 2013
K122940ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3March 19, 2013
K123707ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDEFebruary 28, 2013
K122937SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SDecember 14, 2012
K122796CXI SUPPORT CATHETEROctober 11, 2012