BEUDAMED
    FDA Enforcement Class II Terminated

    LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52

    Recall: Z-1450-2017 · Reported March 22, 2017

    Enforcement

    Recall Number
    Z-1450-2017
    Event ID
    76476
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LeMaitre Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2017
    Initiation Date
    February 7, 2017
    Classification Date
    March 13, 2017
    Termination Date
    September 20, 2019
    Address
    63 2nd Ave, N/A, Burlington, MA, 01803-4413, United States

    Description

    LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52

    Reason

    The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch

    Code Info

    Lot Number/Exp. Date: RST2391 2018-09 RST2394 2018-09 RST2395 2018-09 RST2406 2018-12 RST2407 2018-12 RST2414 2019-02 RST2415 2019-02 RST2421 2019-03 RST2422 2019-03 RST2429 2019-04 RST2430 2019-04 RST2435 2019-05 RST2445 2019-07 RST2446 2019-07 RST2451 2019-08

    Distribution

    Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK

    Quantity

    4673