FDA-Device2018-02-21Class II
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.
Cincinnati Sub-Zero Products LLC
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.
Sold states
US Nationwide Distribution
Affected count
1355 units
Manufactured in
12011 Mosteller Rd, Cincinnati, OH, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0629-2018Don't want to check this manually?
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