BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1444-2017 · Initiated February 7, 2017

    Recall

    Recall Number
    Z-1444-2017
    Event Number
    76476
    Firm
    LeMaitre Vascular, Inc.
    FEI Number
    1220948
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    February 7, 2017
    Terminated
    September 20, 2019
    Address
    63 2nd Ave, Burlington, MA, 01803-4413

    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

    Action

    LeMaitre Vascular, Inc. issued a Dear Doctor letter, on 2/7/17, to distributors and hospitals via FedEx overnight. The letter contains a form that is requested to be returned to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product requested to be returned and replaced. Questions concerning this notice contact 781-221-2266 ext. 183.

    Distribution

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

    Quantity

    608