FDA-Device2016-02-17Class II
Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
C.R. Bard, Inc.
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.
Sold states
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.
Affected count
1,539
Manufactured in
8195 Industrial Blvd NE, N/A, Covington, GA, United States
Products
Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0760-2016Don't want to check this manually?
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