Drug recall
Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
FDA recall event 95961 · Class II · Cook Biotech, Inc.
Key facts
| Event ID | 95961 |
|---|---|
| Recall numbers | Z-0832-2025, Z-0833-2025, Z-0834-2025 |
| Recalling firm | Cook Biotech, Inc. |
| Product type | Devices |
| Products | Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile, Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and, Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. |
| Initiation date | Nov 22, 2024 |
| Report date | Jan 22, 2025 |
| City | W Lafayette |
| State | IN |
| Country | United States |
| FEI number | 3002340648 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: