Cook Biotech, Inc. Recall 95961
Description: Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Cook Biotech, Inc. Recall 95961 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0833-2025 |
| Event ID | 95961 |
| Event Description | Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and |
| Product Type | Devices |
| Distribution | US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea. |
| Quantity | 6 devices |
| Recall Reason | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. |
| Device Classification | 20250122 |
| Device Code Info | Lot #LB1579758, exp. 2/19/2026; Box UDI-DI 10827002314556, Pouch UDI-DI 00827002314559. |
| Center Classification Date | 20250110 |
| Recall Initiation Date | 20241122 |
| Recalling Firm | Cook Biotech, Inc. |
| Initial Notification | |
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