CardioQuip
College Station, TX, US
CardioQuip appears in FDA device records in College Station, TX. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for CardioQuip in 2010.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007899424 | 3007899424 | CardioQuip | 8422 Calibration Ct, College Station, TX 77845 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0566-2024 | 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. | Class II | Open, Classified | |
| Z-0565-2024 | CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A | There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection. | Class II | Open, Classified | |
| Z-0439-2024 | 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. | Class II | Open, Classified | |
| Z-0438-2024 | CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A | There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components. | Class II | Open, Classified | |
| Z-0069-2022 | 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 room during surgery which could result in patient infection. | Class II | Open, Classified | |
| Z-0038-2022 | CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134 | Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. | Class II | Open, Classified | |
| Z-0037-2022 | CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110 | Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. | Class II | Open, Classified | |
| Z-0036-2022 | CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127 | Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. | Class II | Open, Classified | |
| Z-0035-2022 | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain