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CardioQuip, LLC FDA Recalls

9 recalls on file across devices, 0 of them Class I and 9 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16AClass IIOct 24, 2023There is the potential that cooler-heater devices may contai	There is the potential that cooler-heater devices may contain bacterial contamination which could result in pa	Class IIDevices	Oct 24, 2023
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16AClass IIOct 24, 2023There is the potential that cooler-heater devices may contai	There is the potential that cooler-heater devices may contain bacterial contamination which could result in pa	Class IIDevices	Oct 24, 2023
CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16AClass IIOct 19, 2023There is a potential for the heating-chamber to malfunction	There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber	Class IIDevices	Oct 19, 2023
CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16AClass IIOct 19, 2023There is a potential for the heating-chamber to malfunction	There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber	Class IIDevices	Oct 19, 2023
CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heaClass IIJun 24, 2021There is the potential bacterial including Nontuberculous my	There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of h	Class IIDevices	Jun 24, 2021
CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110Class IIMay 12, 2021Labeling does not include guidance for proper water-quality	Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cool	Class IIDevices	May 12, 2021
CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134Class IIMay 12, 2021Labeling does not include guidance for proper water-quality	Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cool	Class IIDevices	May 12, 2021
CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127Class IIMay 12, 2021Labeling does not include guidance for proper water-quality	Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cool	Class IIDevices	May 12, 2021
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103Class IIMay 12, 2021Labeling does not include guidance for proper water-quality	Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cool	Class IIDevices	May 12, 2021

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