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CardioQuip, LLC Recall 88622

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

CardioQuip, LLC Recall 88622 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0035-2022
Event ID88622
Event DescriptionCardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Product TypeDevices
DistributionWorldwide 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.
Quantity1478 units
Recall ReasonLabeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Device Classification20211013
Device Code InfoAll Serial numbers
Center Classification Date20211006
Recall Initiation Date20210512
Recalling FirmCardioQuip, LLC
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