Device product
Centurion- Biopsy Tray TRIBT170 BIOPSY TRAY
Z-1070-2020
Product summary
- Event
- Event 84530
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60
- Official record key
device-enforcement:Z-1070-2020
Official wording
Reason: Incomplete seals on the sterile package may compromise the sterility
Code information: TRIBT170 BIOPSY TRAY 2019052490
Distribution pattern: Nationwide Foreign: GHANA
Derived failure modes
-
Sterility assurance
seals on the sterile package may compromise the sterility