FDA-Device2014-06-11Class II
MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
ConMed Corporation
Hazard
ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed.
Sold states
Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Brazil, Canada, Ecuador, El Salvador, Finland, France, Great Britain, Honduras, India, Indonesia, Israel, Italy, Japan, Latvia, Lebanon, Malaysia, Mexico, Panama, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Thailand, Trinidad, United Arab Emirates and Uruguay.
Affected count
Domestic - 12,600 units, Foreign - 44,280 units
Manufactured in
525 French Rd, Utica, NY, United States
Products
MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1719-2014Don't want to check this manually?
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