FDA-Device2021-10-13Class II
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
CardioQuip, LLC
Hazard
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Sold states
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.
Affected count
1478 units
Manufactured in
8422 Calibration Ct, College Station, TX, United States
Products
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0035-2022Don't want to check this manually?
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