CardioQuip recalls
4 official recalls and safety alerts involving CardioQuip since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with CardioQuip or the relevant agency.
- 2023-12-27
USCardioQuip, LLC recalls CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
FDA · DeviceCardioQuip, LLCUS: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: NoneOfficial notice →- 2023-12-13
- US
CardioQuip, LLC recalls CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
FDA · DeviceCardioQuip, LLCUS Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IAOfficial notice → - 2021-10-13
- US
CardioQuip, LLC recalls CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
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…
FDA · DeviceCardioQuip, LLCWorldwide distribution - US Nationwide distribution including in the states of…Official notice → - US
CardioQuip, LLC recalls CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
FDA · DeviceCardioQuip, LLCWorldwide distribution - US Nationwide distribution in the states of AK, AL,…Official notice →