BEUDAMED
    FDA Enforcement Class II Ongoing

    BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only

    Recall: Z-1937-2025 · Reported June 18, 2025

    Enforcement

    Recall Number
    Z-1937-2025
    Event ID
    96807
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Copan Italia
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 18, 2025
    Initiation Date
    May 2, 2025
    Classification Date
    June 9, 2025
    Address
    Via Francesco Perotti 10, 18, Brescia, N/A, Italy

    Description

    BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only

    Reason

    Swabs for specimen collection may be prone to breakage during product usage.

    Code Info

    Lot: 2415377/UDI: 38053326002145

    Distribution

    US Nationwide distribution in the state of MD.

    Quantity

    81,600 units