Reported Aug 1, 2018 · Terminated
Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating…
Bard Medical Division
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: Bard Medical Division · 8195 Industrial Blvd NE · Covington, GA · 30014-1497
Is this the product you have?
- Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32¿C to 38.5¿C (89.6¿F to 101.3¿F) in adult and pediatric patients of all ages.
- Lot codes and dates
- Model #5000
- Product codes
5000-00-005000-00-00L5000-00-00E5000-01-015000-01-01L5000-01-025000-01-035000-01-045000-01-055000-00-065000-01-075000-01-08. All serial numbers are affected
- Amount recalled
- 5608 Units Total
Where it was sold
Why it was recalled
An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.
This product could cause temporary or reversible health problems — stop using it.
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