BEUDAMED
    FDA Enforcement Class II Ongoing

    Dual Articulating Headrest, Velcro P/N P141210813, REF BF753

    Recall: Z-0984-2024 · Reported February 14, 2024

    Enforcement

    Recall Number
    Z-0984-2024
    Event ID
    93733
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2024
    Initiation Date
    December 12, 2023
    Classification Date
    February 5, 2024
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834, United States

    Description

    Dual Articulating Headrest, Velcro P/N P141210813, REF BF753

    Reason

    Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.

    Code Info

    UDI-DI: 00724995195885, date of manufacture 2023-08-14 thru 2023-10-26.

    Distribution

    Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN, IA, KS, LA, MN, MS, NV, NJ, OH, OK, OR, PA, TN, TX, UT, WA, WI & Puerto Rico, and the countries of Australia, Canada, Mexico & New Zealand.

    Quantity

    80