Device product
Centurion- OR2020 BASIN SET
Z-1088-2020
Product summary
- Event
- Event 84530
- Status
- Terminated
- Classification
- Class II
- Quantity
- 188 units
- Official record key
device-enforcement:Z-1088-2020
Official wording
Reason: Incomplete seals on the sterile package may compromise the sterility
Code information: Lot Codes: 2019020790, 2018111990
Distribution pattern: Nationwide Foreign: GHANA
Derived failure modes
-
Sterility assurance
seals on the sterile package may compromise the sterility