Food, drugs, devices › Cincinnati Sub-Zero Products LLC, a Gentherm Company
Device recall: Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, o
FDA enforcement event 80941 is a device recall by Cincinnati Sub-Zero Products LLC, a Gentherm Company of Cincinnati, OH, initiated 4 Sep 2018 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 23 May 2019. Initiation: voluntary: firm initiated. Cincinnati Sub-Zero Products LLC, a Gentherm Company has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cincinnati Sub-Zero Products LLC, a Gentherm Company, Cincinnati, OH.
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."
Distribution
"US Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0063-2019 | 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… | 270 units | Class II | Terminated | 10 Oct 2018 |
Context
Other enforcement events for Cincinnati Sub-Zero Products LLC, a Gentherm Company
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Jul 2019 | MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conduct | Device | Class III | 1 |
| 2 Jul 2019 | Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The s | Device | Class II | 3 |
| 20 Jun 2019 | Norm-O-Temp model 111Z | Device | Class II | 2 |
| 19 Dec 2018 | Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cool | Device | Class II | 1 |
All 5 events for Cincinnati Sub-Zero Products LLC, a Gentherm Company
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 23 May 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.