BEUDAMED
    FDA Enforcement Class II Ongoing

    CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562

    Recall: Z-0312-2024 · Reported November 22, 2023

    Enforcement

    Recall Number
    Z-0312-2024
    Event ID
    93379
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 22, 2023
    Initiation Date
    November 1, 2023
    Classification Date
    November 16, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562

    Reason

    This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.

    Code Info

    UDI/DI 40193489402446 (case), 10193489402445 (unit): Lot Numbers: 23DMF156, 23CMH030, 23CMD955

    Distribution

    US Nationwide distribution in the state of California.

    Quantity

    1600 kits