Reported May 18, 2016 · Terminated

Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system…

C.R. Bard, 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: C.R. Bard, Inc. · 8195 Industrial Blvd NE · Covington, GA · 30014-1497

Is this the product you have?

  • Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature
Lot codes and dates
    • Product Codes - 5000-00-00
    • 5000-01-01
    • 5000-01-02
    • 5000-01-03
    • 5000-01-04
    • 5000-01-05
Amount recalled
2613

Where it was sold

Why it was recalled

The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This premature coin cell battery drainage could render the device unresponsive upon System startup.

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 Jun 6, 2017 · Data as of Sep 19, 4:44 PM UTC

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