Device product
Centurion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT
Z-1072-2020
Product summary
- Event
- Event 84530
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1100
- Official record key
device-enforcement:Z-1072-2020
Official wording
Reason: Incomplete seals on the sterile package may compromise the sterility
Code information: VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT 2019021290
Distribution pattern: Nationwide Foreign: GHANA
Derived failure modes
-
Sterility assurance
seals on the sterile package may compromise the sterility