Z-3250-2024 Class II Ongoing
FDA device recall Z-3250-2024 was initiated by Cook Biotech, Inc. on August 7, 2024 and is designated Class II. Reason for recall: Products expire prior to the expiration date printed on the product labeling The recall status is ongoing. Affected quantity: 1 unit.
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
- 1 unit
Product Description
Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24667
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-DI: (01)00827002246676(17)250319(10)LB1524471 Lot Number: LB1524471