BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2153-2025 · Initiated June 12, 2025

    Recall

    Recall Number
    Z-2153-2025
    Event Number
    97154
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    LRO
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    June 12, 2025
    Posted
    July 21, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    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.

    Action

    On June 12, 2025, firm instructed customers to request stickers to over-label the affected convenience kits with a warning label indicating to remove the affected component and replace it with product from supply. No product is to be returned.

    Distribution

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

    Quantity

    960 units