FDAFDA · Food and drugs·Recall number Z-0035-2022
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Published October 13, 2021 · Recall initiated: May 12, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- CardioQuip, LLC
- Distributor
- 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.
- Lot
- All Serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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