BEUDAMED
    FDA Recall 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 · Initiated February 24, 2015

    Recall

    Recall Number
    Z-1294-2015
    Event Number
    70698
    Firm
    LeMaitre Vascular, Inc.
    FEI Number
    1220948
    Product Code
    DWQ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    February 24, 2015
    Posted
    March 18, 2015
    Terminated
    May 21, 2015
    Address
    63 2nd Ave, Burlington, MA, 01803-4413

    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

    Action

    LeMaitre Vascular issued a Field Safety Notice/Dear Doctor dated 2/24/15 to customers The letter provides information on the recalled product and instructions on how the customer can inspect for the defective devices and return the affected products for replacement/credit. The letter contains a form that is requested to be returned to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Questions, contact 781-221-2266 ext. 183

    Distribution

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

    Quantity

    54 units