Reported Feb 17, 2016 · Terminated
Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
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 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
- Lot codes and dates
- All lots/serial numbers sold prior to August 2014.
- Amount recalled
- 1,539
Where it was sold
Why it was recalled
Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe.
This product could cause temporary or reversible health problems — stop using it.
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