Cardioquip recalls
Cardioquip appears in 9 official U.S. recall notices indexed by RecallRadar, most recently on 2023-12-27.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 9 |
|---|---|
| Published | 2021-10-13 to 2023-12-27 |
| By agency | FDA Device (9) |
| By classification | Class II (9) |
| By status | ongoing (9) |
| Distribution named in notices | AL, CA, CT, FL, IA, IL, IN, KY, NE, NJ, OH, PA, TX, US, VA, WA, WI, WV |
Recalls
- CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
FDA Device · Class II · 2023-12-27 · Cardioquip
Reason: There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection. - CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
FDA Device · Class II · 2023-12-27 · Cardioquip
Reason: There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection. - CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
FDA Device · Class II · 2023-12-13 · Cardioquip
Reason: There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components. - CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
FDA Device · Class II · 2023-12-13 · Cardioquip
Reason: There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components. - CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
FDA Device · Class II · 2021-10-13 · Cardioquip
Reason: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. - CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
FDA Device · Class II · 2021-10-13 · Cardioquip
Reason: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. - CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
FDA Device · Class II · 2021-10-13 · Cardioquip
Reason: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. - CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
FDA Device · Class II · 2021-10-13 · Cardioquip
Reason: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. - CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices
FDA Device · Class II · 2021-10-13 · Cardioquip
Reason: 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…