Class 2 Device Recall hypo/hyperthermia system

• Date Initiated by Firm: January 05, 2005
• Date Posted: January 26, 2005
• Recall Status: Terminated on March 25, 2005
• Recall Number: Z-0436-05
• Recall Event ID: 30896
• 510(K)Number: K002577 K010338
• Product Classification: System, Thermal Regulating - Product Code DWJ
• Product: Arctic Sun Temperature Management System
• Code Information: Catalog No. 2000-02 (115 volt) and 2000-03 (230 volt) Serial numbers 3001 thru 3080
• Recalling Firm/ Manufacturer: MEDIVANCE INC.; 1172 W Century Dr Ste 240; Louisville CO 80027-1681
• For Additional Information Contact: 303-926-1917
• Manufacturer Reason for Recall: Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.
• FDA Determined Cause: Other
• Action: US customers were notified by telephone on 1/5-6/2005, followed by letter confirmation.
• Quantity in Commerce: 67 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DWJ and Original Applicant = MEDIVANCE, INC.