BEUDAMED
    FDA Enforcement Class II Terminated

    Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

    Recall: Z-0014-2018 · Reported October 18, 2017

    Enforcement

    Recall Number
    Z-0014-2018
    Event ID
    78130
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Handicare AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 18, 2017
    Initiation Date
    July 28, 2016
    Classification Date
    October 11, 2017
    Termination Date
    December 17, 2018
    Address
    Maskinvagen 17, Lulea, N/A, Sweden

    Description

    Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

    Reason

    A limited amount of Carina mobile lifts have been delivered with a too small locking pin. If a locking pin smaller than the correct size is mounted on the Carina mobile lift, the locking pin is likely to cause increased wear on the plastic bushings. In case of continued use, these components may cause wear on the metal of the piston rod eye.

    Code Info

    a) Carina350EM, REF 6060011, Serial numbers: 661102000 - 661102160 b) Carina350EML, REF 60600012, Serial numbers: 661200500 - 661200584 c) Carina350EE, REF 60600009, Serial numbers: 660900500 -660900571

    Distribution

    OH, PA, MD

    Quantity

    9 units