ClearVac Goldline Rocker Switch with Blade Electrode, REF 60-6829-001A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502.
FDA Recall Z-1572-2010 · Posted 2010-05-10
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Recalling FirmConMed Electrosurgery
Recall StatusTerminated
Product CodeGEI
Date Initiated2010-03-29
Date Terminated2010-09-27
Product Quantity2,700 units (US), 2,160 units (Foreign)
Reason for Recall
Electrosurgical pencil may remain activated or self activate after power switch is released.
Firm Action
Customers were notified by letter on March 25, 2010, and were instructed to return all affected devices and to forward the recall information to anyone that may have received the devices to the end user. More information is available by contacting the firm directly at 800-552-0138.
Root Cause
Device Design
Distribution Pattern
Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium, Canada, China, Dominican Republic, El Salvador, Japan, Korea, Mexico, Puerto Rico, Saudi Arabia, Spain, Taiwan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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