BEUDAMED
    FDA Recall Terminated

    Encision ES4107 Disposable AEM Cord, Sterile.

    Recall: Z-1132-04 · Initiated July 9, 2004

    Recall

    Recall Number
    Z-1132-04
    Event Number
    29563
    Firm
    Encision, Inc.
    FEI Number
    1000117361
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 9, 2004
    Posted
    July 22, 2004
    Terminated
    December 14, 2004
    Address
    4828 Sterling Dr, Boulder, CO, 80301-2350

    Description

    Encision ES4107 Disposable AEM Cord, Sterile.

    Reason

    Firm found pinholes in packaging which would compromise sterility.

    Action

    Affected customers were notified by fax or mail on 7/15/2004.

    Distribution

    AL, CA, GA, KS, KY, MI, MN, MS, NC, NH, NY, OH, OK, SD, TN, WA, WY. Foreign Distribution to Australia and Japan. Includes military facilities in GA, MS, and Japan.

    Quantity

    73 units