Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: (01)00827002246683(17)250605(10)LB1536090 (01)00827002246683(17)250627(10)LB1536126 Lot Number: LB1536090, LB1536126
- 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:
- Products expire prior to the expiration date printed on the product labeling
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668
Product Codes/Lot Numbers:
UDI-DI: (01)00827002246683(17)250605(10)LB1536090 (01)00827002246683(17)250627(10)LB1536126 Lot Number: LB1536090, LB1536126
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3251-2024
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Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.