C.R. Bard, Inc. recalls Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US

Recall date

March 31, 2017

Source

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

Recall number

Z-3042-2017

FDA classification

Class II

Brand / firm

C.R. Bard, Inc.

Sold / distributed

Worldwide Distribution - USA (nationwide) to the states of :AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WY., and to the countries of : Australia, Ko…

Why it was recalled

Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.

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 5000 Temperature Management System, 100-120 V North America and 100-120 V US