BEUDAMED
    FDA Recall Open, Classified

    AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,

    Recall: Z-1180-2025 · Initiated December 23, 2024

    Recall

    Recall Number
    Z-1180-2025
    Event Number
    96181
    Firm
    Hollister Incorporated
    FEI Number
    1480288
    Product Code
    CBH
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    December 23, 2024
    Posted
    February 19, 2025
    Address
    2000 Hollister Dr, Libertyville, IL, 60048-3781

    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

    Action

    Hollister issued an URGENT - MEDICAL DEVICE RECALL notice to its consignees on 12/23/2024 via FedEx and email. The notice explained the reason for the recall and potential risk and instructed customers to quarantine affected inventory, discard the product per their local procedures for product destruction, and Please complete and return the response form attached as soon as possible, even if you do not have affected product in your possession and send to [email protected]. For product credit requests: If you are a direct customer of Hollister, contact Hollister Incorporated Customer Service for product credit at: 1-800-323-4060 (prompt #1). If you purchase product from a distributor, please contact your distributor for product credit. Hollister has posted this recall on their website with the link to the page.

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    30,527 box / 366,324 eaches