BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2199-2025 · Initiated June 16, 2025

    Recall

    Recall Number
    Z-2199-2025
    Event Number
    97169
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    QBP
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 16, 2025
    Posted
    July 30, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    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.

    Action

    On June 16, 2025, the firm notified customers of the affected product. Customers were instructed to destroy the affected product for credit.

    Distribution

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

    Quantity

    1,427,100 eaches