# FDA recall Z-0366-2019

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2018-09-12.

## Product

EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

## Reason for recall

Potential ability to leak once used for compounding.

## Distribution

Worldwide distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. Countries of Canada, Australia, New Zealand, China, Hong Kong, Brazil, Chile, and Uruguay.

## Key facts

- **Recall number:** Z-0366-2019
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-12
- **Report date:** 2018-11-07
- **Termination date:** 2020-11-02

- **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-0366-2019

## Citation

> AI Analytics. FDA recall Z-0366-2019. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-0366-2019. Source: US FDA. Licensed CC0.

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