Device product
Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032090 DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2018091790
Z-1050-2020
Product summary
- Event
- Event 84530
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1050-2020
Official wording
Reason: Incomplete seals on the sterile package may compromise the sterility
Code information: Lot Numbers: 2019032090, 2018091790,
Distribution pattern: Nationwide Foreign: GHANA
Derived failure modes
-
Sterility assurance
seals on the sterile package may compromise the sterility