Arctic Sun Temperature Management System recalled over fire hazard

Recall date

June 13, 2018

Source

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

Official notice title

Bard Medical Division recalls Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating…

Recall number

Z-2536-2018

FDA classification

Class II

Brand / firm

Bard Medical Division

Sold / distributed

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, Brusse…

Why it was recalled

An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.

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, 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 32¿C to 38.5¿C (89.6¿F to 101.3¿F) in adult and pediatric patients of all ages.