# FDA recall Z-0247-2020

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2019-09-19.

## Product

TherMax Blood Warmer Unit

## Reason for recall

TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth  connection that can sustain a current of 25 amps for 10 seconds.

## Distribution

Nationwide distribution to Georgia and Maryland.    International distribution to Belgium, Germany, Finland, France, Greece, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom, Australia, and New Zealand

## Key facts

- **Recall number:** Z-0247-2020
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-19
- **Report date:** 2019-11-06
- **Termination date:** 2020-12-11

- **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-0247-2020

## Citation

> AI Analytics. FDA recall Z-0247-2020. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0247-2020. Source: US FDA. Licensed CC0.

---

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