College Station, TX, United States
CardioQuip, LLC recalls
4 recalls recorded since 2018, most recently on 24 October 2023. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)4
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 24 October 2023
- Reason
- There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
- Distribution
- US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0566-2024, Z-0565-2024
- CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
- CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Ongoing Class II Medical devices
- Recall started
- 19 October 2023
- Reason
- There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
- Distribution
- US Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0439-2024, Z-0438-2024
- CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
- CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
Ongoing Class II Medical devices
- Recall started
- 24 June 2021
- 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 during surgery which could result in patient infection.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of TX, PA, FL, CA, HI, SC, OH, AK, NY, IL, AR, WI, MI, AL, KS, NJ, GA, AZ, KY, MS, TN, LA, DE, MA, VA, CO, NE, NC, NH, ME, WV, PA, MO, MN, IN, CT, NH, NV, UT and the country of Venezuela.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0069-2022
- CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
Ongoing Class II Medical devices
- Recall started
- 12 May 2021
- Reason
- Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Germany
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0035-2022, Z-0038-2022, Z-0037-2022, Z-0036-2022
- CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
- CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
- CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
- CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.