BEUDAMED
    FDA Enforcement Class II Ongoing

    Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL

    Recall: Z-1478-2025 · Reported April 9, 2025

    Enforcement

    Recall Number
    Z-1478-2025
    Event ID
    96393
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 9, 2025
    Initiation Date
    February 25, 2025
    Classification Date
    March 28, 2025
    Address
    1941 Stryker Way, Portage, MI, 49002-9711, United States

    Description

    Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL

    Reason

    There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

    Code Info

    5400-030-004 UDI-DI: 07613154340835, Lot Numbers: 2024052333 2023012514 2023050514 2023080912 2024020214; 5400-030-004ITL UDI-DI: 07613327359442, Lot Numbers: 2023071933 2023102714 2024012314

    Distribution

    US Nationwide distribution.

    Quantity

    182,344 total units