FDAJune 17, 2021device

Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

gentherm medicalgentherm

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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