BEUDAMED
    FDA Enforcement Class II Ongoing

    SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301

    Recall: Z-2199-2025 · Reported August 6, 2025

    Enforcement

    Recall Number
    Z-2199-2025
    Event ID
    97169
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 6, 2025
    Initiation Date
    June 16, 2025
    Classification Date
    July 30, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301

    Reason

    SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.

    Code Info

    UDI-DI 00363807103016 (ea) 10363807103013 (box) 20363807103010 (case) Lots 3144609 3144857 3144886 3144967 3145090 3145186

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada and Panama.

    Quantity

    1,427,100 eaches