CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report
Hemotherm¿ Dual Reservoir Cooler/Heater System recalled
Cincinnati Sub-Zero Products is recalling Hemotherm¿ Dual Reservoir Cooler/Heater System, distributed nationwide in the US. The recall was initiated on 27 Nov 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0629-2018
- FDA event ID
- 78173
- Recalling firm
- Cincinnati Sub-Zero Products, Cincinnati, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Nov 2017
- FDA classified
- 15 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 27 Nov 2017 | Recall initiated by company | |
| 15 Feb 2018 | Classified by FDA | +80 days |
| 21 Feb 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
none
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cincinnati Sub-Zero Products
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hemotherm CE recalled by Cincinnati Sub-Zero Products | Cincinnati Sub-Zero Products | Other | 25 states |
| Device | CLASS II | The Hemotherm 400CE 115v, containing power board recalled | Cincinnati Sub-Zero Products | Temperature Abuse | 10 states |
| Device | CLASS II | Cold Therapy Pad - cold water circulating pad, one unit per package recalled | Cincinnati Sub-Zero Products | Packaging Defects | Nationwide |
| Device | CLASS II | 115 V Blanketrol II recalled by Cincinnati Sub-Zero Products | Cincinnati Sub-Zero Products | Temperature Abuse | MI |
| Device | CLASS II | Blanketrol III Data Export recalled by Cincinnati Sub-Zero Products | Cincinnati Sub-Zero Products | Device Malfunction | 6 states |
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