BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564

    Recall: Z-2153-2025 · Reported July 30, 2025

    Enforcement

    Recall Number
    Z-2153-2025
    Event ID
    97154
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 30, 2025
    Initiation Date
    June 12, 2025
    Classification Date
    July 21, 2025
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564

    Reason

    Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.

    Code Info

    UDI/DI 10889942754571 (EA), 40889942754572 (CASE), Lot Numbers: 24EBR566

    Distribution

    Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.

    Quantity

    960 units