Cook Inc.
Cook Inc. appears in FDA public data with 264 recalls — including 42 Class I (most serious) —, 190 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0388-2022, Class II) was initiated on November 12, 2021. Its most recent 510(k) clearance was granted on January 9, 2015.
Summary
- Total Recalls
- 264 (42 Class I)
- 510(k) Clearances
- 190
- Inspections
- 4
- Compliance Actions
- 0
Known Names
cook, cook incorporated, cook endoscopy, cook pacemaker, cook ireland, cook biotech, cook medical incorporated
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0388-2022 | Class II | Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Num | November 12, 2021 |
| Z-0387-2022 | Class II | Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Nu | November 12, 2021 |
| Z-0414-2022 | Class II | Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available w | October 13, 2021 |
| Z-0222-2022 | Class II | Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists | October 8, 2021 |
| Z-0223-2022 | Class II | Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of | October 8, 2021 |
| Z-0185-2022 | Class II | Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheat | September 28, 2021 |
| Z-0186-2022 | Class II | Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G | September 28, 2021 |
| Z-0960-2021 | Class II | Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection dur | January 4, 2021 |
| Z-0600-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introdu | November 24, 2020 |
| Z-0604-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 Flexor Introdu | November 24, 2020 |
| Z-0601-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Introdu | November 24, 2020 |
| Z-0605-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introdu | November 24, 2020 |
| Z-0592-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234 Flexor Introdu | November 24, 2020 |
| Z-0607-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introdu | November 24, 2020 |
| Z-0611-2021 | Class I | Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order N | November 24, 2020 |
| Z-0610-2021 | Class I | Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order N | November 24, 2020 |
| Z-0603-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor Introdu | November 24, 2020 |
| Z-0593-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 Flexor Introdu | November 24, 2020 |
| Z-0591-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introdu | November 24, 2020 |
| Z-0609-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introdu | November 24, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K133130 | BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER | January 9, 2015 |
| K140593 | ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE | December 15, 2014 |
| K132592 | FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET | October 9, 2014 |
| K133597 | CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY | April 18, 2014 |
| K131772 | CANTATA(R) 2.9 MICROCATHETER | February 20, 2014 |
| K131204 | ADVANCE CS CORONARY SINUS INFUSION CATHETER | January 29, 2014 |
| K133634 | SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET | December 23, 2013 |
| K132020 | ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER | October 25, 2013 |
| K131201 | ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE | October 7, 2013 |
| K131206 | COOK CERVICAL RIPENING BALLOON | September 27, 2013 |
| K132334 | TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET | August 16, 2013 |
| K122091 | COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS | July 29, 2013 |
| K130766 | ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE | July 17, 2013 |
| K122917 | CODA BALLOON CATHETER | June 28, 2013 |
| K130293 | ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER | May 31, 2013 |
| K130444 | H-30 HOLMIUM LASER SYSTEM | May 22, 2013 |
| K122940 | ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3 | March 19, 2013 |
| K123707 | ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE | February 28, 2013 |
| K122937 | SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL S | December 14, 2012 |
| K122796 | CXI SUPPORT CATHETER | October 11, 2012 |