BEUDAMED
    FDA Enforcement Class II Ongoing

    AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,

    Recall: Z-1179-2025 · Reported February 26, 2025

    Enforcement

    Recall Number
    Z-1179-2025
    Event ID
    96181
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hollister Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 26, 2025
    Initiation Date
    December 23, 2024
    Classification Date
    February 19, 2025
    Address
    2000 Hollister Dr, N/A, Libertyville, IL, 60048-3781, United States

    Description

    AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,

    Reason

    Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

    Code Info

    UDI/DI 00610075095834, Lot Numbers: 4L172, 4L182

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    45 box / 540 eaches