BEUDAMED
    FDA Recall Terminated

    AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B

    Recall: Z-0470-03 · Initiated January 15, 2003

    Recall

    Recall Number
    Z-0470-03
    Event Number
    25368
    Firm
    Encision, Inc.
    FEI Number
    1000117361
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 15, 2003
    Posted
    January 30, 2003
    Terminated
    April 14, 2003
    Address
    4828 Sterling Drive, Boulder, CO, 80301

    Description

    AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B

    Reason

    Reports of needle fixed-tip electrodes becoming loose or breaking off.

    Action

    All consignees will be notified by phone or visit beginning 01/15/2003.

    Distribution

    Domestic distribution to LA, MA, MN, OR, UT and WA.

    Quantity

    58 devices.