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C.R. Bard, Inc. recalls Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
Recalled February 17, 2016 · FDA recall Z-0760-2016 · C.R. Bard
Hazard
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. · FDA Class II
Units
1,539
Sold at
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.
Description
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.
Product
Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
Manufacturer(s)
C.R. Bard, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →