BEUDAMED
    FDA Enforcement Class II Terminated

    Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.

    Recall: Z-0839-2013 · Reported February 27, 2013

    Enforcement

    Recall Number
    Z-0839-2013
    Event ID
    64288
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Cardiovascular Us Sales, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 27, 2013
    Initiation Date
    December 26, 2012
    Classification Date
    February 20, 2013
    Termination Date
    May 8, 2014
    Address
    45 Barbour Pond Drive, N/A, Wayne, NJ, 07470, United States

    Description

    Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.

    Reason

    ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.

    Code Info

    US Distribution Part number 701017471 Lot numbers 92046825 92065723 92076940 OUS Distribution Part Number Lot Numbers 701002797 92050616 701002797 92052823 701002797 92052913 701002797 92058153 701002797 92063518 701002797 92068260 701002797 92069267 701002797 92072177 701002797 92075413 701002797 92077862 701005092 92081862 701005092 92049129 701005092 92070554 701005093 92049130 701005093 92056899 701005093 92065588 701005093 92069429 701005093 92070553 701005093 92071852 701005093 92073598 701005093 92076875 701017471 92076940 701046644 92063587 701050978 92047882 701050978 92053930 701050978 92054156 701050978 92056171 701050978 92056804 701050978 92065094 701050978 92067382 701050978 92068224 701050978 92069286 701050978 92071806

    Distribution

    Worldwide Distribution-USA including the states of AZ, CO, FL, TN, and TX and the countries of Australia, Canada, Czech Republic, Dubai/Bahrain/Kuwait/Lebanon/Saudi Arabia/Yemen, France, Germany, Hong Kong, Italy, Japan, Netherlands, Singapore, South Africa, Sweden, Switzerland, Thailand, Turkey, and UK.

    Quantity

    41 units - US Distirbution; 216 units - OUS Distribution