Z-0063-2019Class II

Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm Dual Reservoir Cooler/Heater is used to lower...

Name: Z-0063-2019 Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm Dual Reservoir Cooler/Heater is used to lower...
Creator: Cincinnati Sub-Zero Products LLC, a Gentherm Company
Published: 2018-09-04
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2018-09-04 / Terminated / root cause: design

FDA source

Cincinnati Sub-Zero Products LLC, a Gentherm Company began a recall of Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water... on 2018-09-04. FDA classified it as Class II and gives the reason as "Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings". 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-0063-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-04
Posted: 2018-10-03
Terminated: 2019-05-23
Recalling firm: Gentherm Medical, LLC
Product: Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm 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: Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.
Root cause tag: design
FDA root cause: Device Design
Action: On September 4, 2018, the firm, CSZ, issued an "Urgent Medical Device Correction" notices to customers overnight via courier service. Customers were advised to take the following actions: - Immediately examine your inventory and quarantine product subject to the field action. - If you choose to use the product prior to the correction, please consider having a backup device available. - In addition, if you have further distributed this product, please identify your customers and notify them at once of this medical device correction. Your notification to your customers may be enhanced by including a copy of the Urgent Medical Device Correction letter. - Contact CSZ Technical Support (1-888-437-5608) for a replacement kit: Reference FA2017-015 for the Hemotherm control panel kit or you may contact CSZ Technical Support to request replacement by a CSZ representative. - Once the replacement kit is received follow Hemotherm Control Panel Replacement Instructions provided in the kit. - Complete and return the response form provided to acknowledge receipt of the notification and to inform CSZ that customers have performed the requested actions via fax to (513) 772-9119 or via email to [email protected]. If you have any questions, call Kathy DeSmidt @ 513-772-8810.
Quantity in commerce: 270 units
Distribution: US Nationwide Distribution
Product codes and lots: UDI 10613031860221

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0063-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0063-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03

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)