Z-0825-2019Class II

Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE

Name: Z-0825-2019 Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE
Creator: Cincinnati Sub-Zero Products LLC, a Gentherm Company
Published: 2018-12-19
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2018-12-19 / Terminated / root cause: design

FDA source

Cincinnati Sub-Zero Products LLC, a Gentherm Company began a recall of Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or... on 2018-12-19. FDA classified it as Class II and gives the reason as "Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0825-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-19
Posted: 2019-02-13
Terminated: 2020-04-24
Recalling firm: Gentherm Medical, LLC
Product: Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper / hypothermia blanket under the patient to provide warming through conductive heat transfer.
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
Reason for recall: Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down of the device.
Root cause tag: design
FDA root cause: Device Design
Action: Initial notification letters were sent to customers on 12/19/18 to inform them of the upcoming field action. An additional letter sent to customers on 1/18/19 providing instructions on the correction. The letter identified the affected product, problem and actions to be taken.
Quantity in commerce: 396
Distribution: Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, and WI. The products were distributed to the following foreign countries: Columbia and Taiwan.
Product codes and lots: Serial numbers 151-10283CE through 171-10721CE

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0825-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0825-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-20	2019-02-13

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)