Device product
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Z-1896-2026
Product summary
- Firm
- Davol, Inc.
- Event
- Event 98602
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,622 units
- Official record key
device-enforcement:Z-1896-2026
Official wording
Reason: Potential for product to contain foreign matter, confirmed to be inspect fragments.
Code information: Catalog Number: 1050030. UDI: (01)00801741010538(17)270728(10)WBJS0055. Lot Number: WBJS0055. Expiration Date: 07/28/2027
Distribution pattern: Worldwide distribution - US Nationwide and the countries of China, South Korea.
Derived failure modes
-
Foreign material or chemical contamination
foreign matter