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CardioQuip, LLC recalls CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
Recalled October 13, 2021 · FDA recall Z-0036-2022 · CardioQuip
Hazard
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. · FDA Class II
Units
1380 units
Sold at
Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Germany, The Bahamas, Panama, Uruguay.
Description
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Product
CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
Manufacturer(s)
CardioQuip, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →