The Recall Desk
HighFDA (Devices)·Z-0069-2022·Announced 2021-10-13

CardioQuip Modular Cooler-Heater Units Recalled for Bacterial Water Contamination

CardioQuip heater-cooler refrigeration modules used in operating rooms could develop bacterial contamination in water systems, potentially exposing patients to infection during surgery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a high-risk pathogen (nontuberculous mycobacteria) with direct patient exposure risk during surgery. No illnesses have been reported, placing it in the 'High' category per the rubric: risk-of-harm product with serious pathogen potential but without reported illness.

Plain-English summary

CardioQuip, LLC is recalling 1,380 units of the Modular Cooler-Heater 1000(i) Refrigeration Module (Model: MCH-10RMS, all serial numbers) due to a potential safety risk.

The water systems in these heater-cooler devices can accumulate bacterial growth, including nontuberculous mycobacteria (NTM). During surgery, the contaminated water may become aerosolized into the operating room, potentially exposing patients to infection.

These devices have been distributed worldwide, including across all U.S. states and Venezuela. Healthcare facilities using these devices should verify whether they have affected units and follow facility protocols. Patients treated with these devices should consult their healthcare provider if they have concerns about potential exposure.

The recalled product

Product
CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
Manufacturer
CardioQuip, LLC
Category
Medical Device — Surgical Support / Heater-Cooler System
Hazard
  • bacterial-contamination
  • ntm
  • aerosolization

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Serial Numbers

Distribution

Distributed nationwide across the United States.

Related recalls

Same category