FDAFDA · Food and drugs·Recall number Z-3259-2024
Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
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)00827002466029(17)250319(10)LB1524438 (01)00827002466029(17)250523(10)LB1533362 (01)00827002466029(17)250527(10)LB1534031 (01)00827002466029(17)250603(10)LB1534416 Lot Number: LB1524438 LB1533362 LB1534031 LB1534416
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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