CardioQuip Recalls
9 recalls on record · October 13, 2021 to December 27, 2023 · Medical Devices
Recalls by year
21
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 27, 2023Medical DevicesFDA
CardioQuip, LLC recalls CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
Hazard: There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
December 27, 2023Medical DevicesFDA
CardioQuip, LLC recalls CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Hazard: There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
December 13, 2023Medical DevicesFDA
CardioQuip, LLC recalls CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
Hazard: There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
December 13, 2023Medical DevicesFDA
CardioQuip, LLC recalls CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
Hazard: There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
October 13, 2021Medical DevicesFDA
CardioQuip, LLC recalls CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with hea
Hazard: There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.
October 13, 2021Medical DevicesFDA
CardioQuip, LLC recalls CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
Hazard: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
October 13, 2021Medical DevicesFDA
CardioQuip, LLC recalls CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
Hazard: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
October 13, 2021Medical DevicesFDA
CardioQuip, LLC recalls CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
Hazard: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
October 13, 2021Medical DevicesFDA
CardioQuip, LLC recalls CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Hazard: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.