Device product
Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372
Z-3256-2024
Product summary
- Event
- Event 95149
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 39 units
- Official record key
device-enforcement:Z-3256-2024
Official wording
Reason: Products expire prior to the expiration date printed on the product labeling
Code information: UDI: (01)00827002463721(17)250313(10)LB1524444 (01)00827002463721(17)250313(10)LB1524447 (01)00827002463721(17)250319(10)LB1524448 (01)00827002463721(17)250319(10)LB1524473 (01)00827002463721(17)250416(10)LB1525814 (01)00827002463721(17)250419(10)LB1530195 (01)00827002463721(17)250523(10)LB1534372 (01)00827002463721(17)250702(10)LB1539163 Lot Number: LB1524444 LB1524447 LB1524448 LB1524473 LB1525814 LB1530195 LB1534372 LB1539163
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.
Derived failure modes
-
Unknown
Products expire prior to the expiration date printed on the product labeling