Device product
Extra corporeal circuit with bio-active surface.
Z-2495-2020
Product summary
- Event
- Event 85821
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-2495-2020
Official wording
Reason: Affected products failed a sterilization test.
Code information: Lot# 215729283
Distribution pattern: Domestic Distribution only to CA and MI.
Derived failure modes
-
Sterility assurance
failed a sterilization