FDA recall Z-0485-2018

Baxter Healthcare Corporation · Class II · device

Product

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

Reason for recall

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

Distribution

Distribution in the US and Canada.

Key facts

Status
Terminated
Initiation date
2017-07-27
Report date
2018-02-07
Termination date
2020-11-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0485-2018