FDA Device recall Z-2092-2021
Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022
- FDA Device
- Class II
- terminated
- Published 2021-07-28
On 2021-07-28 the FDA classified a Class II recall of Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022 by Gentherm Medical, citing there is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NT….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2092-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-17 |
| Published | 2021-07-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Gentherm Medical |
| Distribution | US |
Product
Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
Reason
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.
Identifiers
| code_info | All units in service life Serial Numbers: 092-10011CE tot 212-11499CE |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2092-2021%22
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