Device product
Central Line Dressing Change Tray
Z-3013-2020
Product summary
- Event
- Event 86341
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 kits
- Official record key
device-enforcement:Z-3013-2020
Official wording
Reason: Potential of incomplete seals impacting the sterility of the kit.
Code information: Lot Number: 2020021990 Product Numbers: DYNDC1928C
Distribution pattern: Domestic Distribution: MN and TX.
Derived failure modes
-
Unknown
Potential of incomplete seals impacting the sterility of the kit.