BEUDAMED
    FDA Recall Terminated

    Radionics Disposable Grounding Plate

    Recall: Z-1121-03 · Initiated July 16, 2003

    Recall

    Recall Number
    Z-1121-03
    Event Number
    26842
    Firm
    Valleylab, Inc
    FEI Number
    1717344
    Product Code
    HAM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 16, 2003
    Posted
    August 12, 2003
    Terminated
    February 18, 2004
    Address
    5920 Longbow Drive, Boulder, CO, 80301

    Description

    Radionics Disposable Grounding Plate

    Reason

    Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.

    Action

    Users were notified by letter on 7/16/2003.

    Distribution

    Nationwide. VA Hospital, San Antonio, TX. Foreign distribution to Australia, Brazil, Canada, Dominican Republic, France, Germany, Hong Kong, India, Israel, Japan, Korea, Phillipines, Singapore, Taiwan.

    Quantity

    25000 pads