BEUDAMED
    FDA Enforcement Class I Terminated

    enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.

    Recall: Z-1386-2019 · Reported July 3, 2019

    Enforcement

    Recall Number
    Z-1386-2019
    Event ID
    82393
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vyaire Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2019
    Initiation Date
    March 13, 2019
    Classification Date
    June 26, 2019
    Termination Date
    September 22, 2020
    Address
    26125 N Riverwoods Blvd, N/A, Mettawa, IL, 60045-3420, United States

    Description

    enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.

    Reason

    Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.

    Code Info

    Part Number: 980202EU. All units distributed through March 7, 2019.

    Distribution

    Worldwide Distribution. US nationwide, Brazil, Canada, Chile, Colombia, Ecuador, Hong Kong, Hungary, Israel, India, Jordan, Korea, Kuwait, Kazakhstan, Lebanon, Macedonia, Mexico, Malaysia , Myanmar, Netherlands, New Zealand, Oman, Peru, Qatar, Russian Federation, Saudi Arabia, Thailand, Turkey, United Republic of Tanzania, South Africa, Panama, and Viet Nam.

    Quantity

    5,782,820 units total