BEUDAMED
    FDA Enforcement Class II Terminated

    LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50

    Recall: Z-1442-2017 · Reported March 22, 2017

    Enforcement

    Recall Number
    Z-1442-2017
    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 (eIFU) REF# e2400-50

    Reason

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

    Code Info

    Lot Number/Exp. Date: RED1743 2018-09 RED1744 2018-09 RED1749 2018-10 RED1750 2018-12 RED1751 2018-12 RED1755 2018-12 RED1756 2018-12 RED1757 2019-01 RED1759 2019-02 RED1760 2019-02 RED1761 2019-03 RED1764 2019-03 RED1766 2019-04 RED1767 2019-04 RED1768 2019-05 RED1769 2019-05 RED1771 2019-06 RED1773 2019-07 RED1774 2019-07 RED1775 2019-07

    Distribution

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

    Quantity

    5601