CardioQuip, LLC: Medical Device Recall in 2021 - (Recall #: Z-0035-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 12, 2021

Date Posted: October 13, 2021

Recall Number: Z-0035-2022

Event ID: 88622

Reason for Recall:

Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

Status: Ongoing

Product Quantity: 1478 units

Code Information:

All Serial numbers

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated