Device product
Centurion-Trays EBSI1021 VALVE CHANGE KIT- DOUBLE
Z-1077-2020
Product summary
- Event
- Event 84530
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1077-2020
Official wording
Reason: Incomplete seals on the sterile package may compromise the sterility
Code information: Product-Lot Code: EBSI1021 VALVE CHANGE KIT- DOUBLE2019050680
Distribution pattern: Nationwide Foreign: GHANA
Derived failure modes
-
Sterility assurance
seals on the sterile package may compromise the sterility