BEUDAMED
    FDA Enforcement Class III Terminated

    LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #61049252

    Recall: Z-1294-2015 · Reported March 25, 2015

    Enforcement

    Recall Number
    Z-1294-2015
    Event ID
    70698
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    LeMaitre Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2015
    Initiation Date
    February 24, 2015
    Classification Date
    March 18, 2015
    Termination Date
    May 21, 2015
    Address
    63 2nd Ave, Burlington, MA, 01803-4413, United States

    Description

    LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #61049252

    Reason

    Mislabeled with an incorrect expiration date

    Code Info

    Lot Number: 61049252 Exp. Date: 2016-06

    Distribution

    CA, CO, KS, MN, UT, WA, WI

    Quantity

    54 units