FDA recall Z-0247-2020

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0247-2020