Class 2 Device Recall Arctic Sun Temperature Management System

• Date Initiated by Firm: June 13, 2018
• Create Date: July 24, 2018
• Recall Status: Terminated on February 16, 2021
• Recall Number: Z-2536-2018
• Recall Event ID: 80375
• 510(K)Number: K161602
• Product Classification: System, thermal regulating - Product Code DWJ
• Product: 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 32C to 38.5C (89.6F to 101.3F) in adult and pediatric patients of all ages.
• Code Information: Model #5000 Product codes: 5000-00-00, 5000-00-00L, 5000-00-00E, 5000-01-01, 5000-01-01L, 5000-01-02, 5000-01-03, 5000-01-04, 5000-01-05, 5000-00-06, 5000-01-07, 5000-01-08. All serial numbers are affected.
• FEI Number: 1018233
• Recalling Firm/ Manufacturer: Bard Medical Division; 8195 Industrial Blvd NE; Covington GA 30014-1497
• For Additional Information Contact: 800-526-4455
• Manufacturer Reason for Recall: An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.
• FDA Determined Cause: Process control
• Action: The firm,Bard Medical, sent a "MEDICAL DEVICE CORRECTION" letter dated 6/13/2018 to its customers. Bard Medical advised their customers to examine inventory and identify any ARCTIC SUN 5000 Temperature Management Systems that match the attached Serial Number List they sent with the letter. The firm also asked their customers to complete the online acknowledgement form(link was provided in the letter) if a customer had an ARCTIC SUN 5000 Temperature Management Systems that matches the serial number list. If a customer had further distributed or transferred an ARCTIC SUN 5000 Temperature Management System, Bard Medical advised the customer to please identify the respective organizations and notify them at once of this communication, including a copy of this communication letter and accompanying attachments and to have the organization promptly complete the online acknowledgement form in the link provided. Upon completion of the online acknowledgement form, the customer will be contacted by a customer service representative to schedule the unit(s) for repair. The link to the Online Acknowledgement Form: www.novasyte.com/as5000 Bard Medical stated they partnered with Novasyte to assist in this action. Novasyte contact information is as follows: Phone: (760) 507-1908 Email: AS5000@novasyte.com
• Quantity in Commerce: 5608 Units Total
• Distribution: Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL,GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Worldwide Distribution: Canada, Austria, Bahrain, Belgium, Brazil, Brussels China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Gibraltar, Greece, Guam, Hungary, Iran, Italy, Jordan, Korea, Luxemburg, Malaysia, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK, Vietnam.
• 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