BEUDAMED
    FDA Enforcement Class II Terminated

    MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.

    Recall: Z-1572-2013 · Reported July 3, 2013

    Enforcement

    Recall Number
    Z-1572-2013
    Event ID
    65417
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Cardiovascular Us Sales, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2013
    Initiation Date
    May 14, 2013
    Classification Date
    June 21, 2013
    Termination Date
    September 18, 2014
    Address
    45 Barbour Pond Drive, Wayne, NJ, 07470, United States

    Description

    MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.

    Reason

    The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector.

    Code Info

    Catalogue Number:Part Number: Lot Number are as follows: (1) 161410 (10 FR.):701022682:92056588 (2) 163610 (10 Fr):70102597:92059789 (3) 163608 (8 Fr.):70102.2681:92065640 (4) 163606 (6 Fr.):70102.2680:92063566

    Distribution

    Worldwide Distribution - US Distribution including the states of Delaware, Illinois, Minnesota , New York., Ohio and Pennsylvania and the countries of Germany, Turkey and France.

    Quantity

    100 units (60 Domestic; 40 International)