Reported Oct 13, 2021 · Ongoing
CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with…
CardioQuip, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CardioQuip, LLC · 8422 Calibration Ct · College Station, TX · 77845-5328
Is this the product you have?
- CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module
- ModelMCH-10RMS
- UDI(01)00860000846127 used with heat exchange devices
- Lot codes and dates
- All Serial Numbers
- Amount recalled
- 1380 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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