BEUDAMED
    FDA Recall Terminated

    ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.

    Recall: Z-0827-2013 · Initiated January 28, 2013

    Recall

    Recall Number
    Z-0827-2013
    Event Number
    64248
    Firm
    ConMed Corporation
    FEI Number
    3001451571
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    January 28, 2013
    Posted
    February 15, 2013
    Terminated
    April 11, 2017
    Address
    525 French Road, Utica, NY, 13502

    Description

    ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.

    Reason

    Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.

    Action

    ConMed sent Urgent Device Recall Letters (dated 1/28/13) and Business Reply Forms to all domestic customers via USPS Priority Mail. International notices were sent via FedEx International Priority to the foreign consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and complete Attachment II response form and return it with unused affected product to: ConMed Corporation 525 French Road, Utica, NY 13502. Customers were asked to return Attachment II even if they don't have any affected product. For questions regarding this recall call 315-624-3533.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.

    Quantity

    Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units