← Every firm
Cook Inc. FDA Recalls
8 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 IntClass IINov 12, 2021Flexor Check-Flo Introducer Ansel Modification mislabeled. |
| Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 InClass IINov 12, 2021Flexor Check-Flo Introducer Ansel Modification mislabeled. |
| Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to proviClass IIOct 13, 2021Specific lots may contain black debris on the exterior of th |
| Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, Class IIOct 8, 2021Transseptal needles may contain rust on the interior and/or |
| Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal neClass IIOct 8, 2021Transseptal needles may contain rust on the interior and/or |
| Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydClass IISep 28, 2021Affected lots may be manufactured incorrectly with the radio |
| Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introduceClass IISep 28, 2021Affected lots may be manufactured incorrectly with the radio |
| Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal SClass IIJan 4, 2021Manufactured with incorrect material, which may result in th |