Arctic Sun Temperature Management System
This recall has been terminated (originally issued January 26, 2005).
- Company
- Medivance Inc.
- Recall Initiated
- January 5, 2005
- Posted
- January 26, 2005
- Terminated
- March 25, 2005
- Recall Number
- Z-0436-05
- Quantity
- 67 units
- Firm Location
- Louisville, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.
Distribution
AL, AZ, CO, DC, FL, GA, IA, IN, KS, MA, MD, MI, MO, NC, NY, OH, PA, TX, VA, WA. No government or military distribution. Foreign distribution to Austria, Belgium, Canada, Germany, Japan, Netherlands, Norway, Scotland.
Lot / Code Info
Catalog No. 2000-02 (115 volt) and 2000-03 (230 volt) Serial numbers 3001 thru 3080
Root Cause
Other
Action Taken
US customers were notified by telephone on 1/5-6/2005, followed by letter confirmation.