# FDA recall Z-0485-2018

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2017-07-27.

## 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

- **Recall number:** Z-0485-2018
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0485-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0485-2018. Source: US FDA. Licensed CC0.

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