FDAFDA · Food and drugs·Recall number Z-3254-2024
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
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)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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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