BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.

    Recall: Z-0619-2025 · Reported December 11, 2024

    Enforcement

    Recall Number
    Z-0619-2025
    Event ID
    95613
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Advanced Medical Solutions Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 11, 2024
    Initiation Date
    October 1, 2024
    Classification Date
    December 4, 2024
    Address
    Unit A, 33 Road One, Winsford, N/A, United Kingdom

    Description

    MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.

    Reason

    Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.

    Code Info

    Model Number: MSC7044EP UDI-DI code: 10080196296842 Lot Number: W00070789 Model Number: MSC7048EP UDI-DI code: 10080196296828 Lot Number: W00070988

    Distribution

    U.S. Nationwide distribution in the states of IL, TX, and VA.

    Quantity

    1,800 boxes