Recall Z-2596-2016— Conmed Corporation

Name: FDA recall Z-2596-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-18

Class II · Terminated

Class II FDA medical device recall by Conmed Corporation, initiated 2016-05-18, terminated 2018-05-24. It names one FDA 510(k) clearance: K140658. Product: Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dispersion and return to the electrosurgical generator.. Reason: 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..

Recalling firm: Conmed Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-05-18
Terminated: 2018-05-24
Firm location: Utica, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K140658 — THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODESConmed Corporation·cleared 2014-07-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dispersion and return to the electrosurgical generator.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.