BEUDAMED
    FDA Enforcement Class II Terminated

    Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.

    Recall: Z-0003-2014 · Reported October 9, 2013

    Enforcement

    Recall Number
    Z-0003-2014
    Event ID
    66026
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cordis Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2013
    Initiation Date
    August 12, 2013
    Classification Date
    October 1, 2013
    Termination Date
    September 30, 2014
    Address
    14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802, United States

    Description

    Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.

    Reason

    Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension.

    Code Info

    Catalog Lots ---------------------------------- 67200000 15918614 67200200 15892736 67200400 15892737, 15897416 67200500 15901314 67203400 15922021 67203600 15897418 67204000 15925687 67205200 15892738, 15892739 67205400 15885645, 15887472, 15897420 67205600 15901319 67206000 15897422 67207200 15892740 67208000 15892741 67208200 15887473, 15887474, 15897424 67208300 15901321 67212600 15916942 67213000 15916943 67227000 15901323

    Distribution

    Worldwide Distribution - USA Nationwide in the states of AZ, CA, FL, ID, LA, MA, MD, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TX, VA, WI, and WV and the countries of: Austria, Belgium, Czech Republic, France, Germany, Greece,Hungary, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Switzerland, United Arab, and United Kingdom

    Quantity

    1238 units