BEUDAMED
    FDA Enforcement Class II Ongoing

    AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,

    Recall: Z-1180-2025 · Reported February 26, 2025

    Enforcement

    Recall Number
    Z-1180-2025
    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, Oral Endotracheal Tube Fastener, REF 9799,

    Reason

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

    Code Info

    UDI/DI 00610075129386, Lot Numbers: Lot, 4I192, 4I202, 4I212, 4I222, 4I232, 4I242, 4I252, 4I262, 4I272, 4I282, 4I292, 4I302, 4J012, 4J022, 4J032, 4J042, 4J052, 4J062, 4J072, 4J082, 4J092, 4J102, 4J112, 4J122, 4J132, 4J142, 4J152, 4J162, 4J212, 4J222, 4J232, 4J242, 4J252, 4J262, 4J272, 4J282, 4J292, 4J302, 4J312, 4K012, 4K022, 4K032, 4K042, 4K052, 4K062, 4K072, 4K082, 4K092, 4K102, 4K112, 4K122, 4K132, 4K142, 4K152, 4K162, 4K172, 4K182, 4K192, 4K202, 4K212, 4K222, 4K232, 4K242, 4K252, 4K262, 4K272, 4K282, 4K292, 4K302, 4L012, 4L022, 4L032, 4L042, 4L092, 4L112, 4L122, 4L132, 4L142, 4L152, 4L162, 4L172, 4L182.

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    30,527 box / 366,324 eaches