Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #LB1576761, exp. 1/21/2025; and Lot #LB1577308, exp. 1/21/2025; Box UDI-DI 10827002602851, Pouch UDI-DI 00827002602854.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Cook Biotech, Inc.
- Reason for Recall:
- Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Product Codes/Lot Numbers:
Lot #LB1576761, exp. 1/21/2025; and Lot #LB1577308, exp. 1/21/2025; Box UDI-DI 10827002602851, Pouch UDI-DI 00827002602854.
Distribution:
Distributed in: US, IN, MI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0832-2025
Related Recalls
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Products expire prior to the expiration date printed on the product labeling