BEUDAMED
    FDA Recall Terminated

    Rocker Switch Electrosurgical Pencil with E-Z Clean Tip

    Recall: Z-0778-06 · Initiated April 6, 2006

    Recall

    Recall Number
    Z-0778-06
    Event Number
    35124
    Firm
    Megadyne Medical Products, Inc
    FEI Number
    1721194
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 6, 2006
    Posted
    April 19, 2006
    Terminated
    August 3, 2006
    Address
    11506 S State St, Draper, UT, 84020-9453

    Description

    Rocker Switch Electrosurgical Pencil with E-Z Clean Tip

    Reason

    Surgical device packaging may be damaged and may compromise sterility.

    Action

    Consignees were notified by letter on 04/06/2006.

    Distribution

    Nationwide, including one VA facility in OH. No military consignees. Foreign distribution to France, India, Ireland, Japan, South Korea, Malaysia, Poland, UK.

    Quantity

    34,132 units