CardioQuip, LLC
Medical device manufacturer in College Station, TX.
1510(k) clearances
0PMA approvals
9recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K102147 | Cardioquip Modular Cooler-Heater Model MCH-1000DWC · Traditional | 11/19/2010SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0566-2024 Class II | CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16AThere is the potential that cooler-heater devices may contain bacterial contamination which could result in… | 10/24/2023Open, Classified |
| Z-0565-2024 Class II | CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16AThere is the potential that cooler-heater devices may contain bacterial contamination which could result in… | 10/24/2023Open, Classified |
| Z-0439-2024 Class II | CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16AThere is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater… | 10/19/2023Open, Classified |
| Z-0438-2024 Class II | CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16AThere is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater… | 10/19/2023Open, Classified |
| Z-0069-2022 Class II | CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI:…There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of… | 06/24/2021Open, Classified |
| Z-0038-2022 Class II | CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model:…Labeling does not include guidance for proper water-quality maintenance and device inspection for heater… | 05/12/2021Open, Classified |
| Z-0037-2022 Class II | CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI:…Labeling does not include guidance for proper water-quality maintenance and device inspection for heater… | 05/12/2021Open, Classified |
| Z-0036-2022 Class II | CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797…Labeling does not include guidance for proper water-quality maintenance and device inspection for heater… | 05/12/2021Open, Classified |
| Z-0035-2022 Class II | CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103Labeling does not include guidance for proper water-quality maintenance and device inspection for heater… | 05/12/2021Open, Classified |