Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Reported: January 22, 2025 Initiated: November 22, 2024 #Z-0832-2025
Product Description
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Reason for Recall
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Details
- Recalling Firm
- Cook Biotech, Inc.
- Units Affected
- 49 devices
- Distribution
- US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
- Location
- W Lafayette, IN
Frequently Asked Questions
What product was recalled? ▼
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.. Recalled by Cook Biotech, Inc.. Units affected: 49 devices.
Why was this product recalled? ▼
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2025. Severity: Moderate. Recall number: Z-0832-2025.
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