CardioQuip, LLC
FDA Regulatory Profile
CardioQuip, LLC appears in FDA public data with 9 recalls, 1 510(k) clearance, 3 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0565-2024, Class II) was initiated on October 24, 2023. Its most recent 510(k) clearance was granted on November 19, 2010.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 1
- Inspections
- 3
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0565-2024 | Class II | CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A | October 24, 2023 |
| Z-0566-2024 | Class II | CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A | October 24, 2023 |
| Z-0439-2024 | Class II | CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A | October 19, 2023 |
| Z-0438-2024 | Class II | CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A | October 19, 2023 |
| Z-0069-2022 | Class II | CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000 | June 24, 2021 |
| Z-0038-2022 | Class II | CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: | May 12, 2021 |
| Z-0037-2022 | Class II | CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000 | May 12, 2021 |
| Z-0036-2022 | Class II | CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860 | May 12, 2021 |
| Z-0035-2022 | Class II | CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103 | May 12, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K102147 | CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 | November 19, 2010 |