CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
Reported: October 13, 2021 Initiated: May 12, 2021 #Z-0038-2022
Product Description
CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
Reason for Recall
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Details
- Recalling Firm
- CardioQuip, LLC
- Units Affected
- 369 uniyd
- 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, The Bahamas, Panama, Uruguay.
- Location
- College Station, TX
Frequently Asked Questions
What product was recalled? ▼
CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134. Recalled by CardioQuip, LLC. Units affected: 369 uniyd.
Why was this product recalled? ▼
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 13, 2021. Severity: Moderate. Recall number: Z-0038-2022.
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