Device product
Centurion-Trays DYNTray, surgicalJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION TRAY
Z-1076-2020
Product summary
- Event
- Event 84530
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1076-2020
Official wording
Reason: Incomplete seals on the sterile package may compromise the sterility
Code information: Product-Lot Code: DYNJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL 2018111390 DYNJ1000 NEWBORN CIRCUMCISION TRAY 2019021890
Distribution pattern: Nationwide Foreign: GHANA
Derived failure modes
-
Sterility assurance
seals on the sterile package may compromise the sterility