BEUDAMED
    FDA Enforcement Class II Terminated

    Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.

    Recall: Z-1143-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1143-2013
    Event ID
    64538
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elana, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    February 14, 2013
    Classification Date
    April 18, 2013
    Termination Date
    May 9, 2013
    Address
    10480 Little Patuxent Pkwy, Suite 400, Columbia, MD, 21044-3568, United States

    Description

    Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.

    Reason

    Distribution of an unapproved device into interstate commerce.

    Code Info

    Model 280, S/N 776, S/N 706, S/N 758

    Distribution

    Distributed in the states of Pennsylvania, Texas, and New York.

    Quantity

    3 devices