Reported Oct 2, 2024 · Ongoing
Biodesign Fistula Plug C-FPS-0.4 - 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-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas
- Order Number (GPN)G54613
- Lot codes and dates
- UDI(01)00827002546134(17)
- Lot NumberLB1524481¿
LB1524439LB1524440LB1524442LB1524443LB1524445LB1524463LB1524466LB1524468LB1524475LB1524479
LB1524490LB1524493LB1525896LB1525901LB1525907LB1526905LB1527067LB1527075LB1530306LB1530313LB1531711LB1531739LB1533341LB1533352LB1536078LB1536107LB1537839LB1537859LB1539734LB1539735LB1540185
- Amount recalled
- 93
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.
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