Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54614
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: (01)00827002546141(17) Lot Number: LB1524449 LB1524454 LB1524460 LB1524465 LB1524482 LB1526801 LB1526803 LB1526900 LB1528808 LB1528812 LB1529886 LB1529893 LB1530966 LB1530984 LB1533320 LB1533329 LB1534893 LB1534902 LB1537013 LB1537052 LB1537834 LB1537846
- 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-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54614
Product Codes/Lot Numbers:
UDI: (01)00827002546141(17) Lot Number: LB1524449 LB1524454 LB1524460 LB1524465 LB1524482 LB1526801 LB1526803 LB1526900 LB1528808 LB1528812 LB1529886 LB1529893 LB1530966 LB1530984 LB1533320 LB1533329 LB1534893 LB1534902 LB1537013 LB1537052 LB1537834 LB1537846
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3254-2024
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