FDAFDA · Food and drugs·Recall number Z-3251-2024
Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668
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-DI: (01)00827002246683(17)250605(10)LB1536090 (01)00827002246683(17)250627(10)LB1536126 Lot Number: LB1536090, LB1536126
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.