BEUDAMED
    FDA Enforcement Class II Ongoing

    Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433

    Recall: Z-1919-2026 · Reported April 29, 2026

    Enforcement

    Recall Number
    Z-1919-2026
    Event ID
    98659
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Windstone Medical Packaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 29, 2026
    Initiation Date
    March 11, 2026
    Classification Date
    April 22, 2026
    Address
    1602 4th Ave N, N/A, Billings, MT, 59101-1521, United States

    Description

    Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433

    Reason

    The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).

    Code Info

    UDI-DI: B098AMS144330; Lot Numbers: 204612 206723 210211 213641 216064 222060 224073 225012 236012 236910

    Distribution

    US Nationwide distribution in the states of GA, OR, TN, and WA.

    Quantity

    475 units