Z-3252-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2024
- Initiation Date
- August 7, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 units
Product Description
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
Reason for Recall
Products expire prior to the expiration date printed on the product labeling
Distribution Pattern
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.
Code Information
UDI: (01)00827002546127(17) Lot Number: LB1524461 LB1524469 LB1524472 LB1524486 LB1529402 LB1531398 LB1537840 LB1537858