FDA-Device2013-01-30Class II
Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 60-7524-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
ConMed Corporation
Hazard
ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
Sold states
Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatemala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.
Affected count
313,190 (total for all devices)
Manufactured in
525 French Road, N/A, Utica, NY, United States
Products
Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 60-7524-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0722-2013Don't want to check this manually?
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