FDAJune 24, 2021device
CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
cardioquip
UPCs
00860000846127
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A2023-10-24
- FDACardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A2023-10-24
- FDACardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A2023-10-19
- FDACardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A2023-10-19
- FDACardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 008600008461272021-05-12
- FDACardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 008600008461342021-05-12
- FDACardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)008600008461032021-05-12
- FDACardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)008600008461102021-05-12
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