Conmed Corporation: 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.

Agency Publication Date: August 19, 2016

Affected Products

Product: 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.

Beginning Lot Code 141001X with Ending Lot Code 20150705X.

Lot Numbers:

Code

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.

Beginning Lot Code 141001X with Ending Lot Code 20150705X.

Lot Numbers:

Code

Product: 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.

Beginning Lot Code 141001X with Ending Lot Code 20150705X.

Lot Numbers:

Code

Product: Adult Dual Dispersive Electrodes (for patients >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 7-382. Intended to be used for the dispersion and return to the electrosurgical generator.

Beginning Lot Code 141001X with Ending Lot Code 20150705X.

Lot Numbers:

Code

Product: 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.

Beginning Lot Code 141001X with Ending Lot Code 20150705X.

Lot Numbers:

Code

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73607

Status: Resolved

Manufacturer: Conmed Corporation

Manufactured In: United States

Units Affected: 5 products (307,684 units; 4,480 units; 6,640 units; 124,333 units; 4,560 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Beginning Lot Code 141001X with Ending Lot Code 20150705X.

Lot Numbers:

Code

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.

Beginning Lot Code 141001X with Ending Lot Code 20150705X.

Lot Numbers:

Code

Beginning Lot Code 141001X with Ending Lot Code 20150705X.

Lot Numbers:

Code

Beginning Lot Code 141001X with Ending Lot Code 20150705X.

Lot Numbers:

Code

Beginning Lot Code 141001X with Ending Lot Code 20150705X.

Lot Numbers:

Code