FDA Enforcement
Class II
Ongoing
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
Recall: Z-3252-2024
·
Reported October 2, 2024
Enforcement
- Recall Number
- Z-3252-2024
- Event ID
- 95149
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cook Biotech, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 2, 2024
- Initiation Date
- August 7, 2024
- Classification Date
- September 25, 2024
- Address
- 1425 Innovation Pl, W Lafayette, IN, 47906-1000, United States
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
Products expire prior to the expiration date printed on the product labeling
Code Info
UDI: (01)00827002546127(17) Lot Number: LB1524461 LB1524469 LB1524472 LB1524486 LB1529402 LB1531398 LB1537840 LB1537858
Distribution
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.
Quantity
35 units