BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A

    Recall: Z-2131-2023 · Reported July 19, 2023

    Enforcement

    Recall Number
    Z-2131-2023
    Event ID
    92486
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    July 19, 2023
    Initiation Date
    May 18, 2023
    Classification Date
    July 12, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A

    Reason

    Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".

    Code Info

    GTIN 10889942851850, Batch Numbers: 2023011090, 2023011190, 2023011790, 2023012090, 2023012590, 2023020790, 2023022390, 2023022490

    Distribution

    Worldwide distribution - US Nationwide and the country of Panama.

    Quantity

    183240 units