Device product
Centurion-Skin Prep Trays SP1180 DRY PREP SET SP200 SKIN SCRUB TRAY SP415 STERILE GAUZE SPONGE
Z-1092-2020
Product summary
- Event
- Event 84530
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1092-2020
Official wording
Reason: Incomplete seals on the sterile package may compromise the sterility
Code information: Product/Description/Lot Numbers: SP1180 DRY PREP SET 2019032690 SP200 SKIN SCRUB TRAY 2019051390 SP415 STERILE GAUZE SPONGE 2019011090, 2018120390
Distribution pattern: Nationwide Foreign: GHANA
Derived failure modes
-
Sterility assurance
seals on the sterile package may compromise the sterility