—#145059

Product

Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature

FDA product code: DWJ — System, Thermal Regulating
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K101092
Affected lot / code info: Product Codes - 5000-00-00, 5000-01-01, 5000-01-02, 5000-01-03, 5000-01-04, 5000-01-05

Why it was recalled

The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This premature coin cell battery drainage could render the device unresponsive upon System startup.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

BARD sent an Urgent Medical Product Recall to all affected consignees on November 9, 2015. The letter indicates that a technician will contract the firm for the evaluation and potential replacement of the affected electronic components. The technician will fill out the Field Action Effectiveness Check Form after evaluation. Customers with questions were instructed to call 1-770-784-6471 or email bmd@crbard.com. For questions regarding this recall call 770-784-6220.

Recalling firm

Firm: C.R. Bard, Inc.
Address: 8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

Distribution pattern: Worldwide Distribution to AL, AK, AZ, AR, CA, CO, CT, DEL, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Finland, France, Germany, Gibraltar, Greece, Guam, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Oman, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom

Timeline

Recall initiated: 2015-11-09
Posted by FDA: 2016-05-06
Terminated: 2017-06-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #145059. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.