# FDA recall Z-1570-2022

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2022-07-14.

## Product

The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.

## Reason for recall

There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.

## Distribution

Worldwide distribution: US Nationwide, Canada, Uruguay, Argentina, Brazil, Colombia, Dominican Republic, Panama, Puerto Rico, Hong Kong, Taiwan, Korea, United Kingdom, Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Kuwait, Netherlands, Oman, Poland, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates.

## Key facts

- **Recall number:** Z-1570-2022
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-14
- **Report date:** 2022-08-31

- **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-1570-2022

## Citation

> AI Analytics. FDA recall Z-1570-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1570-2022. Source: US FDA. Licensed CC0.

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