Reported Mar 23, 2016 · Terminated

Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz.…

Sorin Group USA, Inc.

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: Sorin Group USA, Inc. · 14401 W 65th Way · Arvada, CO · 80004-3503

Is this the product you have?

    • Stockert Heater-Cooler 3T
    • Item Number 16-02-8
    • H3T/240V/60Hz
    • 16-02-82
    • H3T208V/60Hz
    • 16-02-85
    • H3T/120V/60Hz. Device Listing E572259
Lot codes and dates
    • All Serial Numbers for Item Number 16-02-81
    • 16-02-82
    • 16-02-85
Amount recalled
1125 units

Where it was sold

  • Nationwide
  • VA

Why it was recalled

On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the standard for German drinking water.

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

Notice updated May 26, 2017 · Data as of Sep 19, 6:02 PM UTC

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