Device product
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
Z-0485-2018
Product summary
- Event
- Event 78042
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29,088 units
- Official record key
device-enforcement:Z-0485-2018
Official wording
Reason: A leak may allow for microbial contamination of the sterile fluid path.
Code information: Product Code 2J8003, Lot No. DR16J18096.
Distribution pattern: Distribution in the US and Canada.
Derived failure modes
-
Microbial contamination
microbial contamination