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ConMed Corporation recalls Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 60-7526-001, Sterile, Rx ONLY -- CONM
Recalled January 30, 2013 · FDA recall Z-0723-2013 · ConMed
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. · FDA Class II
Units
313,190 (total for all devices)
Sold at
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.
Description
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.
Product
Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 60-7526-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Manufacturer(s)
ConMed Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →