C.R. Bard, Inc. recalls Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.

Recall date

November 10, 2015

Source

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

Recall number

Z-0760-2016

FDA classification

Class II

Brand / firm

C.R. Bard, Inc.

Sold / distributed

Nationwide Distribution-DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI. IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

Why it was recalled

Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe.

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 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.