BEUDAMED
    FDA Recall Terminated

    EMCEE OBTURATOR (7F) for use with 8F Sheath, REF #92580008, packaged in individual labeled pouches, 10 units per box, 40 boxes per case. Firm on label: Schneider/NAMIC, Glens Falls, New York 12801

    Recall: Z-1021-05 · Initiated June 24, 2004

    Recall

    Recall Number
    Z-1021-05
    Event Number
    32286
    Firm
    Boston Scientific Corp
    FEI Number
    3017892510
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 24, 2004
    Posted
    July 20, 2005
    Terminated
    July 21, 2005
    Address
    10 Glens Falls, Tech Park Glens Falls, NY, 12801-3864

    Description

    EMCEE OBTURATOR (7F) for use with 8F Sheath, REF #92580008, packaged in individual labeled pouches, 10 units per box, 40 boxes per case. Firm on label: Schneider/NAMIC, Glens Falls, New York 12801

    Reason

    Product labeled to contain Emcee Obturators contained Emcee Dilators.

    Action

    Phone calls to one consignee on 6/24/2004 and the 2nd U.S. consignee on 6/30/2004. The foreign consignee was notified via mail on 10/18/2004.

    Distribution

    Domestic: Two consignees in NJ and IN. Foreign: One consignee in Belgium.

    Quantity

    90 units