BEUDAMED
    FDA Recall Terminated

    AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.

    Recall: Z-1074-04 · Initiated June 11, 2004

    Recall

    Recall Number
    Z-1074-04
    Event Number
    29430
    Firm
    Encision, Inc.
    FEI Number
    1000117361
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 11, 2004
    Posted
    September 22, 2004
    Terminated
    November 9, 2004
    Address
    4828 Sterling Dr, Boulder, CO, 80301-2350

    Description

    AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.

    Reason

    Electrosurgical tip may break or come off during use.

    Action

    Customers were notified beginning 6/15/2004 by phone or visit.

    Distribution

    AL, CT, GA, IA, MN, MS, NC, OK, OR, TN, WA. Foreign distribution to Canada and Australia.

    Quantity

    335 units