FDA-Device2012-12-05Class II
Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.
Kimberly-Clark Corporation
Hazard
Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.
Sold states
Nationwide Distribution including AZ, AK, CA, CO, DE, DC, FL, GA. ID, IL, IN, IA, KS, KY, LA, MD, ME MA, MS, MO, MT, NE, NJ, NM, NV, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WV, and WI
Affected count
400 units
Manufactured in
1400 Holcomb Bridge Rd, N/A, Roswell, GA, United States
Products
Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0451-2013Don't want to check this manually?
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