Device product
Centurion-BIOPSY TRAY BT205A MINOR SET UP BIOPSY TRAY BT345A HH PACK BIOPSY
Z-1062-2020
Product summary
- Event
- Event 84530
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1062-2020
Official wording
Reason: Incomplete seals on the sterile package may compromise the sterility
Code information: Lot Numbers: BT205A MINOR SET UP BIOPSY TRAY 2019012490 BT345A HH PACK BIOPSY 2019040590, 2019021290
Distribution pattern: Nationwide Foreign: GHANA
Derived failure modes
-
Sterility assurance
seals on the sterile package may compromise the sterility