FDAFDA · Food and drugs·Recall number Z-3252-2024
Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54612
Published October 2, 2024 · Recall initiated: August 7, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Products expire prior to the expiration date printed on the product labeling
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cook Biotech, Inc.
- Distributor
- 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.
- Lot
- UDI: (01)00827002546127(17) Lot Number: LB1524461 LB1524469 LB1524472 LB1524486 LB1529402 LB1531398 LB1537840 LB1537858
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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