FDA recall Z-1834-2022

Cook Incorporated · Class II · device

Product

Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-260 G00590 C-SF-25-50 G01938 TSF-35-180 G00652 C-SF-18-40 G02255 TSF-25-145 G00617 TSF-32-145 G00638 C-SF-15-50 G02274 TSF-18-145 G00587 TSF-18-50 G00593 TSF-35-145 G00650 TSF-21-145 G00602 THSF-35-180 G01237 TSF-35-80 G00664 C-SF-25-30 G02163 C-SF-21-30 G02351 THSF-35-80 G02408

Reason for recall

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

Key facts

Status: Ongoing
Initiation date: 2022-08-16
Report date: 2022-10-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1834-2022