Device product
Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.
Z-0109-2014
Product summary
- Event
- Event 66222
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49,344 units
- Official record key
device-enforcement:Z-0109-2014
Official wording
Reason: Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471
Code information: R13D09024, R13D09107, R13D12101, R13D17068, R13D18066, R13D20070
Distribution pattern: Nationwide distribution.
Derived failure modes
-
Unknown
Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471