Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Recall
- Recall Number
- Z-0832-2025
- Event Number
- 95961
- Firm
- Cook Biotech, Inc.
- FEI Number
- 3002340648
- Product Code
- KHJ
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- November 22, 2024
- Posted
- January 10, 2025
- Address
- 1425 Innovation Pl, W Lafayette, IN, 47906-1000
Description
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
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: [email protected]. If you have any questions or concerns, please contact Cook Biotech at 765-807-7888.
US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
49 devices