Device product
Centurion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAY
Z-1090-2020
Product summary
- Event
- Event 84530
- Status
- Terminated
- Classification
- Class II
- Quantity
- 108 units
- Official record key
device-enforcement:Z-1090-2020
Official wording
Reason: Incomplete seals on the sterile package may compromise the sterility
Code information: Product/Description/Lot Numbers: SB1280 SKIN SCRUB KIT 2018112690 SB1525 VAGINAL PREP TRAY 2018103190
Distribution pattern: Nationwide Foreign: GHANA
Derived failure modes
-
Sterility assurance
seals on the sterile package may compromise the sterility