FDA-Device2017-08-23Class II
Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
C.R. Bard, Inc.
Hazard
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.
Sold states
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, Korea, Japan, Canada, Hong Kong, China, Singapore, & EMEA
Affected count
3,450 units
Manufactured in
8195 Industrial Blvd NE, N/A, Covington, GA, United States
Products
Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3042-2017Don't want to check this manually?
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