Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Recalled by Cincinnati Sub-Zero Products LLC Due to Due to FDA's safety communication relating to nontuberculous...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cincinnati Sub-Zero Products LLC directly.
Affected Products
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.
Quantity: 1355 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cincinnati Sub-Zero Products LLC
Cincinnati Sub-Zero Products LLC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report