FDA-Device2013-02-27Class II
ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
ConMed Corporation
Hazard
Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
Sold states
Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.
Affected count
Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units
Manufactured in
525 French Road, N/A, Utica, NY, United States
Products
ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0826-2013Don't want to check this manually?
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