Device product
Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
Z-0084-2015
Product summary
- Event
- Event 69181
- Status
- Terminated
- Classification
- Class I
- Quantity
- 94,224
- Official record key
device-enforcement:Z-0084-2015
Official wording
Reason: Particulate matter found inside the fluid path.
Code information: Product code: 2B8011 Lot Number: UR13D15112
Distribution pattern: Nationwide Distribution including Puerto Rico, and the country of Canada.
Derived failure modes
-
Foreign material or chemical contamination
Particulate matter