FDA recall Z-0833-2025

Cook Biotech, Inc. · Class II · device

Product

Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and

Reason for recall

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

Distribution

US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.

Key facts

Status
Ongoing
Initiation date
2024-11-22
Report date
2025-01-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
W Lafayette, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0833-2025