CardioQuip, LLC

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
1
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0566-2024Class IICardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16AOctober 24, 2023
Z-0565-2024Class IICardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16AOctober 24, 2023
Z-0438-2024Class IICardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16AOctober 19, 2023
Z-0439-2024Class IICardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16AOctober 19, 2023
Z-0069-2022Class IICardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000June 24, 2021
Z-0037-2022Class IICardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000May 12, 2021
Z-0038-2022Class IICardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI:May 12, 2021
Z-0036-2022Class IICardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860May 12, 2021
Z-0035-2022Class IICardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103May 12, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K102147CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000November 19, 2010