BEUDAMED
    FDA Enforcement Class I Terminated

    Sara Plus Active Floor Lift

    Recall: Z-1098-2022 · Reported June 1, 2022

    Enforcement

    Recall Number
    Z-1098-2022
    Event ID
    89960
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    ARJOHUNTLEIGH POLSKA Sp. z.o.o.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 1, 2022
    Initiation Date
    April 5, 2022
    Classification Date
    May 20, 2022
    Termination Date
    September 5, 2024
    Address
    Ul. Ks. Piotra Wawrzyniaka 2, Komorniki, N/A, Poland

    Description

    Sara Plus Active Floor Lift

    Reason

    The device may emit smoke or ignite.

    Code Info

    Model Numbers: HEP0001, HEP0001-AU, HEP0001-BR, HEP0001-CN, HEP0001-JP, HEP0001-UK, HEP0001-US, HEP1001, HEP1001-AU, HEP1001CON4869, HEP1001-US, HEP2001, HEP2001-BR, HEP2001-CN, HEP2001-UK

    Distribution

    US Nationwide and Worldwide distribution

    Quantity

    4449 devices