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Recall Observatory FDA recall evidence

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

July 27, 2017

Class II

Product summary

Firm
Baxter Healthcare Corporation
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

    reason.microbial_contamination · v1.0.0

    microbial contamination