Biodesign Fistula Plug C-FPS-0.7 - For implantation to recall: Labeling Error
Biodesign Fistula Plug C-FPS-0.7 - 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 - For implantation to 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)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
- Product
- Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN)…
- Recalling firm
- Cook Biotech, Inc.
- Quantity
- 102 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)