CardioQuip, LLC recalls CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103

Recall date

May 12, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0035-2022

FDA classification

Class II

Brand / firm

CardioQuip, LLC

Sold / distributed

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 German…

Why it was recalled

Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103