Medical device recalls Moderate risk

Baxter Healthcare Corporation recalls Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and adminis…

Recall date
July 27, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0485-2018
FDA classification
Class II
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
Distribution in the US and Canada.

Why it was recalled

A leak may allow for microbial contamination of the sterile fluid path.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.

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