Z-2092-2021Class II

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

Name: Z-2092-2021 Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm...
Creator: Gentherm Medical, LLC
Published: 2021-06-17
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2021-06-17 / Terminated / root cause: manufacturing process

FDA source

Gentherm Medical, LLC began a recall of Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures on 2021-06-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2092-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-17
Posted: 2021-07-19
Terminated: 2023-03-01
Recalling firm: Gentherm Medical, LLC
Product: Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 6/17/2021, Gentherm issued Urgent Medical Device Recall notices and response forms to customers via courier service. Instructions to Customers: 1) Immediately examine your inventory, access updated manuals and ensure obsolete manuals are removed from service. 2) Updated manuals may be accessed via www.gentherm.com or physicial copies may be requested from Gentherm Medical, LLC at 1-888-437-5608. 3) Ensure that all users are informed of the contents of this letter. 4) If you have further distributed this product, please provide those accounts with a copy of this notice. 5) Complete and return the customer response form via email to [email protected].
Quantity in commerce: 1448 devices (1010 US; 438 OUS)
Distribution: 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
Product codes and lots: All units in service life Serial Numbers: 092-10011CE tot 212-11499CE

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2092-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2092-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-19

Product code DWC

K122813Class IIHemotherm Model 400Ce Cooler/heater SystemCincinnati Sub-Zero Products, Inc. / cleared 2012-12-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)