Hemotherm Dual Reservoir Cooler/Heater System Recall for Updated Cleaning Instructions
Cincinnati Sub-Zero is recalling 1,355 Hemotherm units to provide updated instructions for cleaning and disinfection to address NTM infection risks.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall addresses a high-risk pathogen (NTM) and a risk-of-harm product where the specific hazard is infection, fitting the criteria for a High severity score.
Plain-English summary
Cincinnati Sub-Zero Products LLC is recalling 1,355 units of the Hemotherm Dual Reservoir Cooler/Heater System, Models 400CE and 400MR. These devices are used in medical settings to warm or cool blood for adult, pediatric, or infant patients. The recall is being conducted due to FDA safety communications regarding nontuberculous mycobacteria (NTM) infections associated with heater/cooler devices.
The recall involves the distribution of updated Instructions For Use that include a more robust cleaning and disinfection procedure. The agency has classified this recall as Class II. The affected units were distributed nationwide in the United States.
Healthcare facilities and users of these devices should review the updated instructions and implement the new cleaning and disinfection protocols to mitigate the risk of NTM infections.
The recalled product
- 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
- Manufacturer
- Cincinnati Sub-Zero Products LLC
- Affected units
- 1,355
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- none
Distribution
Distributed nationwide across the United States.
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