# FDA recall Z-0167-2020

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2019-09-18.

## Product

EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes:    1. H938737, 250mL;      2. H938738, 500mL;      3. H938739, 1000mL;      4. H938740, 2000mL;      5. H938741, 3000mL  Product Usage: The EXACTAMIX Empty EVA bags are used as the destination container in compounding of large-volume sterile solutions for further administration to a single patient. The empty bags are used at pharmacies and compounding centers by pharmacists and pharmacy technicians to compound multi-ingredient solutions, as prescribed by a physician.

## Reason for recall

Potential ability to leak once used for compounding.

## Distribution

Worldwide distribution  - UD Nationwide including 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.    The countries of Canada, Australia, New Zealand, Singapore, Korea, Taiwan, Thailand, Hong Kong, Brazil, Columbia, Mexico, Chile, Uruguay, Dominican Republic, Panama, Bermuda.

## Key facts

- **Recall number:** Z-0167-2020
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-18
- **Report date:** 2019-10-30
- **Termination date:** 2021-02-16

- **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-0167-2020

## Citation

> AI Analytics. FDA recall Z-0167-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0167-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*