Z-0833-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2025
- Initiation Date
- November 22, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 devices
Product Description
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 Pattern
US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
Code Information
Lot #LB1579758, exp. 2/19/2026; Box UDI-DI 10827002314556, Pouch UDI-DI 00827002314559.