BEUDAMED
    FDA Enforcement Class I Ongoing

    Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1

    Recall: Z-2734-2020 · Reported August 12, 2020

    Enforcement

    Recall Number
    Z-2734-2020
    Event ID
    85912
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 12, 2020
    Initiation Date
    June 26, 2020
    Classification Date
    August 6, 2020
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690, United States

    Description

    Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1

    Reason

    Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

    Code Info

    Model Numbers: 4000-0105-249, 4000-0105-50, 4000-0105-51, 4000-0105-78, 4000-0106-00, 4000-0106-01, and 4000-0106-231. Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1

    Distribution

    Worldwide distribution - United Arab Emirates, United States, Afghanistan, Albania, Australia, Belgium, Bermuda, Canada, China, Germany, Denmark, Great Britain, Hong Kong, Indonesia, Ireland, India, Korea, Kuwait, Lebanon, Mexico, Malaysia, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Saudi Arabia, Trinidad and Tobago

    Quantity

    35616 units