Baxter Healthcare Corporation recalls TherMax Blood Warmer Unit

Recall date

September 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0247-2020

FDA classification

Class II

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TherMax Blood Warmer Unit