Conmed Corporation recalls Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Bir…

Recall date

May 18, 2016

Source

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

Recall number

Z-2599-2016

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 Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems, 10' (3.05m) Cable, Catalog Number 7-383. Intended to be used for the dispersion and return to the electrosurgical generator.