BEUDAMED
    FDA Recall Terminated

    Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.

    Recall: Z-1055-2013 · Initiated March 18, 2013

    Recall

    Recall Number
    Z-1055-2013
    Event Number
    64704
    Firm
    LeMaitre Vascular, Inc.
    FEI Number
    1220948
    Product Code
    KFX
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    March 18, 2013
    Posted
    April 4, 2013
    Terminated
    December 3, 2014
    Address
    63 2nd Ave, Burlington, MA, 01803-4413

    Description

    Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (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.

    Action

    LeMaitre sent an "URGENT:VASCUTAPE RADIOPAQUE TAPE DEVICE FIELD SAFETY NOTICE" dated March 20, 2013 to affected customers. The recall letter contains a form that requests customers to return to LeMaitre Vascular, Inc. as a record of notification and reconciliation. The letter provides instructions on how the customer can inspect the defective tape seals and/or return the affected products for replacement/credit.

    Distribution

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

    Quantity

    13560