FDA recall Z-0035-2022

Product

CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103

Reason for recall

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, The Bahamas, Panama, Uruguay.

Key facts

Status

Ongoing

Initiation date

2021-05-12

Report date

2021-10-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

College Station, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0035-2022