Food, drugs, devices › Cincinnati Sub-Zero Products LLC, a Gentherm Company
Device recall: Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The s
Cincinnati Sub-Zero Products LLC, a Gentherm Company (Cincinnati, OH) initiated this device recall on 2 Jul 2019; FDA lists 3 product records under event 83464, classified Class II.
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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 22 Jun 2020. 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
"Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes"
Distribution
"Worldwide distribution - US Nationwide and countries of Afghanistan, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bhutan, Brazil, Brunei, Canada Chile, China, Colombia,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0417-2020 | Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads. | 3932 | Class II | Terminated | 27 Nov 2019 |
| Z-0418-2020 | Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads. | 3726 | Class II | Terminated | 27 Nov 2019 |
| Z-0419-2020 | CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads. | 5291 | Class II | Terminated | 27 Nov 2019 |
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 |
| 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 |
| 4 Sep 2018 | Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, o | 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: "Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes"
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: "Worldwide distribution - US Nationwide and countries of Afghanistan, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bhutan, Brazil, Brunei, Canada Chile, China, Colombia,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Jun 2020. "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.