FDA-Device2016-08-31Class II
Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310. Intended to be used for the dispersion and return to the electrosurgical generator.
Conmed Corporation
Hazard
A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
Sold states
Worldwide Distribution -- USA, including AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico; and, the countries of Australia, Canada, Belgium, Brunei Darussalam, China, France, Guatemala, Hong Kong, Israel, Italy, Japan, South Korea, Malaysia, Mexico, New Zealand, Norway, Portugal, Saudi Arabia, Spain, Sweden, and United Arab Emirates.
Affected count
307,684 units
Manufactured in
310 Broad St, Utica, NY, United States
Products
Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310. Intended to be used for the dispersion and return to the electrosurgical generator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2595-2016Don't want to check this manually?
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