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Bard Medical Division recalls Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulati
Recalled August 1, 2018 · FDA recall Z-2536-2018 · Bard Medical Division
Hazard
An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system. · FDA Class II
Units
5608 Units Total
Sold at
Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL,GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Worldwide Distribution: Canada, Austria, Bahrain, Belgium, Brazil, Brussels China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Gibraltar, Greece, Guam, Hungary, Iran, Italy, Jordan, Korea, Luxemburg, Malaysia, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK, Vietnam.
Description
An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.
Product
Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32¿C to 38.5¿C (89.6¿F to 101.3¿F) in adult and pediatric patients of all ages.
Manufacturer(s)
Bard Medical Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →