Device product
Centurion IVS3505 ULTRASOUND GUIDED PIV KIT
Z-1084-2020
Product summary
- Event
- Event 84530
- Status
- Terminated
- Classification
- Class II
- Quantity
- 350
- Official record key
device-enforcement:Z-1084-2020
Official wording
Reason: Incomplete seals on the sterile package may compromise the sterility
Code information: Lot Code: 2019012390
Distribution pattern: Nationwide Foreign: GHANA
Derived failure modes
-
Sterility assurance
seals on the sterile package may compromise the sterility