Device product
Centurion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790
Z-1068-2020
Product summary
- Event
- Event 84530
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1068-2020
Official wording
Reason: Incomplete seals on the sterile package may compromise the sterility
Code information: 67465 STERILE SIMS UTERINE SOUND (83360) 2019032790
Distribution pattern: Nationwide Foreign: GHANA
Derived failure modes
-
Sterility assurance
seals on the sterile package may compromise the sterility