Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
This recall is currently active, issued January 10, 2025. It was issued by Cook Biotech, Inc..
- Company
- Cook Biotech, Inc.
- Recall Initiated
- November 22, 2024
- Posted
- January 10, 2025
- Recall Number
- Z-0833-2025
- Quantity
- 6 devices
- Firm Location
- W Lafayette, IN
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot #LB1579758, exp. 2/19/2026; Box UDI-DI 10827002314556, Pouch UDI-DI 00827002314559.
Root Cause
Under Investigation by firm
Action Taken
The recalling firm issued two different emails on 11/22/2024, one informing the direct account that the devices either had an incorrect IFU revision (Biodesign Otologic Butterfly Graft, ENT-OTO-BFLY-0.4-0.6) or had an incorrect expiration date (Biodesign Hiatal Hernia Graft, C-PHR, and Biodesign Dural Graft, C-DUR); and the other informing a different direct account that the product had an incorrect IFU revision for two lots (for Biodesign Otologic Butterfly Graft, ENT-OTO-BFLY-0.4-0.6). The direct accounts informed the recalling firm, and the recalling firm issued "URGENT: MEDICAL DEVICE RECALL" letters to its customers dated 12/10/2024. The letters instructed the customers to examine inventory and quarantine affected product, return the products to Cook Biotech Inc with a copy of a completed "Acknowledge and Receipt Form even if you do not have affected product(s) on hand; share notice and immediately report adverse events to Cook Biotech by phone 765-807-7888 or by email to: biotech.feedback@rtix.com. If you have any questions or concerns, please contact Cook Biotech at 765-807-7888.