BEUDAMED
    FDA Enforcement Class II Terminated

    LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.

    Recall: Z-1054-2013 · Reported April 10, 2013

    Enforcement

    Recall Number
    Z-1054-2013
    Event ID
    64704
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LeMaitre Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 10, 2013
    Initiation Date
    March 18, 2013
    Classification Date
    April 4, 2013
    Termination Date
    December 3, 2014
    Address
    63 2nd Ave, N/A, Burlington, MA, 01803-4413, United States

    Description

    LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.

    Reason

    Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.

    Code Info

    LSG1130, exp. 2017-04; LSG1132, exp. 2017-11

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.

    Quantity

    6970