CardioQuip recalls MCH-10RMS refrigeration modules used in surgery due to potential bacterial growth in water systems that could infect patients during procedures.
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.
CardioQuip is recalling its MCH-10RMS refrigeration modules because bacteria could grow in the water system and be aerosolized during surgery, risking patient infection. This is a serious hazard that requires immediate attention to prevent infections.
The water system in these modules can support bacterial growth, including dangerous Nontuberculous mycobacteria. If contaminated water is aerosolized during surgery, it could lead to patient infections.
Surgical teams using CardioQuip MCH-10RMS modules in operating rooms are at risk. Patients undergoing surgery with these devices could be exposed to contaminated water.
Check for the model MCH-10RMS with serial numbers starting with (01)00860000846127. These modules are used with heat exchange devices in surgical settings.
Discontinue use of the recalled MCH-10RMS refrigeration module to prevent potential patient exposure to contaminated water.
The water system in these modules can grow bacteria like Nontuberculous mycobacteria, which could become aerosolized during surgery and infect patients.
Immediately stop using the module and contact CardioQuip for instructions on replacement or disposal.
Yes, patients undergoing surgery with these modules could be exposed to contaminated water, leading to infections.
We’ve drafted a message you can send CardioQuip to request your refund or repair — edit it as you like.
Subject: Recall Z-0069-2022 — CardioQuip CardioQuip Hello, I own a CardioQuip that is covered by recall Z-0069-2022 from CardioQuip. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
