Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372

Class I - Dangerous

🏥 Medical Devices Recalled: August 7, 2024 Cook Biotech Implants & Prosthetics Nationwide

What Should You Do?

Check if you have this product:
UDI: (01)00827002463721(17)250313(10)LB1524444 (01)00827002463721(17)250313(10)LB1524447 (01)00827002463721(17)250319(10)LB1524448 (01)00827002463721(17)250319(10)LB1524473 (01)00827002463721(17)250416(10)LB1525814 (01)00827002463721(17)250419(10)LB1530195 (01)00827002463721(17)250523(10)LB1534372 (01)00827002463721(17)250702(10)LB1539163 Lot Number: LB1524444 LB1524447 LB1524448 LB1524473 LB1525814 LB1530195 LB1534372 LB1539163
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-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372

Product Codes/Lot Numbers:

UDI: (01)00827002463721(17)250313(10)LB1524444 (01)00827002463721(17)250313(10)LB1524447 (01)00827002463721(17)250319(10)LB1524448 (01)00827002463721(17)250319(10)LB1524473 (01)00827002463721(17)250416(10)LB1525814 (01)00827002463721(17)250419(10)LB1530195 (01)00827002463721(17)250523(10)LB1534372 (01)00827002463721(17)250702(10)LB1539163 Lot Number: LB1524444 LB1524447 LB1524448 LB1524473 LB1525814 LB1530195 LB1534372 LB1539163