Reported Oct 2, 2024 · Ongoing
Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal…
Cook Biotech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Biotech, Inc. · 1425 Innovation Pl · W Lafayette, IN · 47906-1000
Is this the product you have?
- 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
- Lot codes and dates
- UDI(01)00827002546141(17)
- Lot Number
LB1524449LB1524454LB1524460LB1524465LB1524482LB1526801LB1526803LB1526900LB1528808LB1528812LB1529886LB1529893LB1530966LB1530984LB1533320LB1533329LB1534893LB1534902LB1537013LB1537052LB1537834LB1537846
- Amount recalled
- 102 units
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
Why it was recalled
Products expire prior to the expiration date printed on the product labeling
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Cook Biotech, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.