Reported Oct 13, 2021 · Ongoing

CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127

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), Standard Unit
  • Model
    • MCH-10RMS
    • CE 2797
  • UDI(01) 00860000846127
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

Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.