Device product
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
Z-2407-2024
Product summary
- Event
- Event 94831
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 39,010 units (All US)
- Official record key
device-enforcement:Z-2407-2024
Official wording
Reason: Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
Code information: Product Number: 1963; UDI/DI: 10705031003132 (primary), 20705031003139 (box of 10); Lot numbers:
Distribution pattern: Worldwide distribution - US Nationwide and the countries of India and Japan.
Derived failure modes
-
Sterility assurance
pouches were found torn open, impacting the sterile