Biodesign Fistula Plug C-FPS-0.7-2 - For implantation recall: Labeling Error
Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN)…
Why was Biodesign Fistula Plug C-FPS-0.7-2 - For implantation recalled?
Products expire prior to the expiration date printed on the product labeling
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: (01)00827002463738(17)250319(10)LB1524437 (01)00827002463738(17)250319(10)LB1524441 (01)00827002463738(17)250319(10)LB1524453 (01)00827002463738(17)250402(10)LB1524456 (01)00827002463738(17)250319(10)LB1524457 (01)00827002463738(17)250402(10)LB1524484 (01)00827002463738(17)250408(10)LB1524495 (01)00827002463738(17)250402(10)LB1525243 (01)00827002463738(17)250416(10)LB1525244 (01)00827002463738(17)250402(10)LB1525249 (01)00827002463738(17)250416(10)LB1528983 (01)00827002463738(17)250416(10)LB1528999 (01)00827002463738(17)250416(10)LB1529377 (01)00827002463738(17)250626(10)LB1529380 (01)00827002463738(17)250429(10)LB1529383 (01)00827002463738(17)250419(10)LB1529680 (01)00827002463738(17)250429(10)LB1530192 (01)00827002463738(17)250429(10)LB1530299 (01)00827002463738(17)250429(10)LB1530308 (01)00827002463738(17)250520(10)LB1530309 (01)00827002463738(17)250523(10)LB1530310 (01)00827002463738(17)250531(10)LB1531363 (01)00827002463738(17)250531(10)LB1531404 (01)00827002463738(17)250531(10)LB1531406 (01)00827002463738(17)250603(10)LB1534887 (01)00827002463738(17)250626(10)LB1534888 Lot Number: LB1524437 LB1524441 LB1524453 LB1524456 LB1524457 LB1524484 LB1524495 LB1525243 LB1525244 LB1525249 LB1528983 LB1528999 LB1529377 LB1529380 LB1529383 LB1529680 LB1530192 LB1530299 LB1530308 LB1530309 LB1530310 LB1531363 LB1531404 LB1531406 LB1534887 LB1534888
- Product
- Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN)…
- Recalling firm
- Cook Biotech, Inc.
- Quantity
- 130 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, United Kingdom.
- Recall date
- October 2, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)