FDA-Device2019-11-06Class II
TherMax Blood Warmer Unit
Hazard
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.
Sold states
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
Affected count
504 units total
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
TherMax Blood Warmer Unit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0247-2020More Baxter Healthcare Corporation recalls
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