Arctic Sun Temperature Management System recalled over fire hazard

Recall date

November 9, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

C.R. Bard, Inc. recalls Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indica…

Recall number

Z-1617-2016

FDA classification

Class II

Brand / firm

C.R. Bard, Inc.

Sold / distributed

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, Canad…

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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