Device product
STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
Z-0481-2023
Product summary
- Event
- Event 91124
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 80 kits
- Official record key
device-enforcement:Z-0481-2023
Official wording
Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information: a) 9430: UDI/DI (case) M75294301, UDI/DI (kit)M75294301, Serial/Lot Numbers: 22270492023 b) 9431: UDI/DI (case) M75294301, UDI/DI (kit)M75294301, Serial/Lot Numbers: 22255491774, 22255491484
Distribution pattern: US nationwide distribution, and Canada.
Derived failure modes
-
Labeling or packaging
bag being incompletely sealed, which may result in a breach
-
Sterility assurance
bag being incompletely sealed, which may result in a breach in the sterility