Gentherm recalls Hemotherm 400CE blood cooler/heater units due to potential contamination and infection risks during surgery. Affected units have serial numbers 092-10011CE to 212-11499CE.
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.
Gentherm is recalling its Hemotherm 400CE blood cooler/heater devices because contaminated water in the unit could spread infections during surgery. This affects all units with serial numbers from 092-10011CE to 212-11499CE.
The device's water system can grow harmful bacteria like Nontuberculous mycobacteria. Contaminated water may become airborne in the operating room during surgery, potentially infecting patients.
Healthcare professionals using the device during surgery are most at risk. Patients undergoing cardiopulmonary bypass procedures may be exposed to infection if the device is contaminated.
Check the serial number on the device, which ranges from 092-10011CE to 212-11499CE. The device is used to cool or warm blood during heart surgery procedures.
Look for the serial number on the device, which should be between 092-10011CE and 212-11499CE.
The device can grow harmful bacteria in its water system, which may become airborne during surgery and infect patients.
Check the serial number on the device; affected units have numbers from 092-10011CE to 212-11499CE.
The recall does not specify a remedy, so contact Gentherm Medical for guidance.
We’ve drafted a message you can send Gentherm to request your refund or repair — edit it as you like.
Subject: Recall Z-2092-2021 — Gentherm Gentherm Hello, I own a Gentherm that is covered by recall Z-2092-2021 from Gentherm. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
