Recall Z-0069-2022— CardioQuip, LLC

Name: FDA recall Z-0069-2022
Creator: U.S. Food and Drug Administration
Published: 2021-06-24

Class II · Ongoing

Class II FDA medical device recall by CardioQuip, LLC, initiated 2021-06-24. It names one FDA 510(k) clearance: K102147. Product: CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.. Reason: 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..

Recalling firm: CardioQuip, LLC
Classification: Class II
Status: Ongoing
Initiated: 2021-06-24
Firm location: College Station, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K102147 — CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000Cardioquip Llp·cleared 2010-11-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.