CardioQuip, LLC: Medical Device Recall in 2021 - (Recall #: Z-0069-2022)

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 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.

Product Classification:

Class II

Date Initiated: June 24, 2021

Date Posted: October 13, 2021

Recall Number: Z-0069-2022

Event ID: 88621

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 1380 units

Code Information:

All Serial Numbers

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated