BEUDAMED
    FDA Enforcement Class I Terminated

    FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.

    Recall: Z-1706-2015 · Reported June 17, 2015

    Enforcement

    Recall Number
    Z-1706-2015
    Event ID
    71054
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Cardiovascular Us Sales, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2015
    Initiation Date
    April 2, 2015
    Classification Date
    June 8, 2015
    Termination Date
    July 6, 2016
    Address
    45 Barbour Pond Drive, N/A, Wayne, NJ, 07470, United States

    Description

    FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.

    Reason

    In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation.

    Code Info

    Article number 66 77 200 66 77 300 66 77 400 Serial Numbers 1058 1646 2034 2723 1059 1647 2095 2724 1060 1648 2186 2729 1172 1650 2554 2731 1201 1651 2555 2732 1202 1652 2556 2733 1204 1653 2557 2735 1224 1654 2558 2736 1225 1655 2559 2737 1226 1656 2560 2738 1277 1657 2561 2739 1280 1786 2562 2740 1281 1787 2613 2741 1282 1860 2714 2742 1545 1861 2716 2743 1546 2021 2719 2744 1643 2022 2720 2745 1644 2023 2721 2746 1645 2024 2722 2747

    Distribution

    Class I Recall - Worldwide distribution -- US, including the states of AL, AZ, DC, FL, MI, MO, NJ, NY, OR, PA, TX, and WV; and, countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Libya, Mexico, Mongolia, Mozambique, Netherlands, Norway Oman, Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Unites States, and Venezuela.

    Quantity

    1641 [80 units (US) 1561 units (OUS)]