Device product
Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
Z-0194-2016
Product summary
- Event
- Event 72362
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,440 units
- Official record key
device-enforcement:Z-0194-2016
Official wording
Reason: Leakage from the inlet port of the 15L Cycler Drainage Bags.
Code information: H15C11095
Distribution pattern: US Distribution and Internationally to Canada.
Derived failure modes
-
Unknown
Leakage from the inlet port of the 15L Cycler Drainage Bags.