BEUDAMED
    FDA Recall Terminated

    Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may equal -100, -115, -220 and -230.

    Recall: Z-0144-04 · Initiated September 15, 2003

    Recall

    Recall Number
    Z-0144-04
    Event Number
    27659
    Firm
    ConMed Electrosurgery
    FEI Number
    3004491689
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 15, 2003
    Posted
    November 19, 2003
    Terminated
    July 1, 2004
    Address
    7211 S Eagle St, Centennial, CO, 80112-4203

    Description

    Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may equal -100, -115, -220 and -230.

    Reason

    The Hyfrecator 2000 units were released without documented adherence to their voltage output specification.

    Action

    All customers were notified by certified letter on 9/15/03. Mailing to the Phillipines by registered mail also on 9/15/03. Firm requests that the units be returned for testing or the replacement with another unit.

    Distribution

    Units were distributed to CA, CT,IL and ME. International distribution to Phillipines.

    Quantity

    10 units