Conmed Corporation recalls Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. In…

Recall date

May 18, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2597-2016

FDA classification

Class II

Brand / firm

Conmed Corporation

Sold / distributed

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…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used for the dispersion and return to the electrosurgical generator.