Reported Aug 23, 2017 · Ongoing

Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US

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 5000 Temperature Management System, 100-120 V North America and 100-120 V US
Lot codes and dates
  • Product Codes 5000-00-00 & 5000-00-00E - All serial numbers
Amount recalled
3,450 units

Where it was sold

Why it was recalled

Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.

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 Aug 28, 2017 · Data as of Sep 19, 5:34 PM UTC

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