FDA-Device2012-08-15Class II
Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System - Model 1000 Control Unit and Energy Transfer Pads is a thermal regulating system, indicated for monitoring and controlling patient temperature.
Kimberly-Clark Corporation
Hazard
A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to lose its ability to warm and maintain set temperature and may also result in excessive heat with the fuse assembly that could lead to the generation of smoke.
Sold states
Nationwide Distribution-including the states of AZ, CA, CO, DE, FL, GA, IA, ID, IN, IL, KS, KY, LA, MA, MD, ME, MO, MS, NE, NM, OH, OR, PA, RI, SC, TN, TX, VA, WI and WV.
Affected count
129 units
Manufactured in
1400 Holcomb Bridge Rd, Roswell, GA, United States
Products
Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System - Model 1000 Control Unit and Energy Transfer Pads 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-2181-2012Don't want to check this manually?
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