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Cincinnati Sub-Zero Products LLC recalls Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circul
Recalled February 21, 2018 · FDA recall Z-0629-2018 · Cincinnati Sub-Zero Products
Hazard
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. · FDA Class II
Units
1355 units
Sold at
US Nationwide Distribution
Description
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.
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 that enters and exits a blood heat exchanger for adult, pediatric or infant patients.
Manufacturer(s)
Cincinnati Sub-Zero Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →