BEUDAMED
    FDA Enforcement Class II Terminated

    LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52

    Recall: Z-1444-2017 · Reported March 22, 2017

    Enforcement

    Recall Number
    Z-1444-2017
    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 Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52

    Reason

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

    Code Info

    Lot Number/Ex Date: RED1746 2018-09 RED1753 2018-12 RED1762 2019-03 RED1765 2019-03 RED1779 2019-09

    Distribution

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

    Quantity

    608