Z-0629-2018Class II

Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR

Name: Z-0629-2018 Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR
Creator: Cincinnati Sub-Zero Products LLC
Published: 2017-11-27
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2017-11-27 / Terminated / root cause: design

FDA source

Cincinnati Sub-Zero Products LLC began a recall of Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature... on 2017-11-27. FDA classified it as Class II and gives the reason as "Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure". 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-0629-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-27
Posted: 2018-02-13
Terminated: 2018-07-02
Recalling firm: Gentherm Medical, LLC
Product: Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
Reason for recall: Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure.
Root cause tag: design
FDA root cause: Device Design
Action: Between November 27, 2017 - December 8, 2017, Cincinnati Sub-Zero Products LLC, distributed Urgent Medical Device Correction notices to their customers via Email and USPS. This Medical Device Correction has been initiated to provide a labeling update to the cleaning & disinfection procedures. The update addresses the disinfection process, cleaning of reusable accessories, as well as clarifying the water type that should be used with the Hemotherm. Customers are encouraged to do the following: 1) Discard your current Hemotherm Operation & Technical Manual and/or Operation Manual. 2) Replace your current Hemotherm Operation & Technical Manual and/or Operation Manual with the enclosed updated Manual(s). For your convenience, all updates have been highlighted in the manuals. " For Hemotherm 400CE users, utilize the P/N 56418-R Operation & Technical Manual and P/N 56075-G Operation Manuals. " For Hemotherm 400MR users, utilize the P/N 56234-S Operation Manual. All customers are encouraged to complete and return the enclosed response form by fax or email to [email protected]; Fax: 513-772-9119. Customers with questions or concerns, please contact the Field Action Coordinator: Kathy DeSmidt, E-mail: [email protected], Phone: 513-772-8810 or 800-989-7373.
Quantity in commerce: 1355 units
Distribution: US Nationwide Distribution
Product codes and lots: none

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0629-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0629-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-15

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)