Biodesign Fistula Plug C-FPS-0.4-2 - For implantation recall: Labeling Error
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)…
Why was Biodesign Fistula Plug C-FPS-0.4-2 - 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)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
- Product
- 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)…
- Recalling firm
- Cook Biotech, Inc.
- Quantity
- 39 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)