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Gentherm Medical Recalls
2 recalls on record · July 28, 2021 to January 19, 2022 · Medical Devices
Recalls by year
21
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 19, 2022Medical DevicesFDA
Gentherm Medical, LLC recalls Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Hazard: This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
July 28, 2021Medical DevicesFDA
Gentherm Medical, LLC recalls Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during c
Hazard: There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surgery which could lead to patient infection.