Device product
Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
Z-0085-2015
Product summary
- Event
- Event 69181
- Status
- Terminated
- Classification
- Class I
- Quantity
- 20448
- Official record key
device-enforcement:Z-0085-2015
Official wording
Reason: Particulate matter found inside the fluid path.
Code information: Product code 2B8013 Lot Number: UR13K14095
Distribution pattern: Nationwide Distribution including Puerto Rico, and the country of Canada.
Derived failure modes
-
Foreign material or chemical contamination
Particulate matter