Home / Recalls / Gentherm Medical, LLC / Z-2092-2021

Z-2092-2021 Class II Terminated

Recalled by Gentherm Medical, LLC — Blue Ash, OH

FDA device recall Z-2092-2021 was initiated by Gentherm Medical, LLC on June 17, 2021 and is designated Class II. Reason for recall: 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 wat… The recall status is terminated (terminated March 1, 2023). Affected quantity: 1448 devices (1010 US; 438 OUS).

Recall Details

Product Type: Devices
Report Date: July 28, 2021
Initiation Date: June 17, 2021
Termination Date: March 1, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1448 devices (1010 US; 438 OUS)

Product Description

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

Reason for Recall

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.

Distribution Pattern

Worldwide distribution. US nationwide, including Puerto Rico; Argentina, Bangladesh, Chile, Colombia, France, Guatemala, Hungary, India, Indonesia, Israel, Italy, Nepal, Nigeria, Pakistan, Philippines, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Thailand, Turkey, UAE

Code Information

All units in service life Serial Numbers: 092-10011CE tot 212-11499CE