BEUDAMED
    FDA Enforcement Class II Terminated

    PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012 A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.

    Recall: Z-0777-2013 · Reported February 13, 2013

    Enforcement

    Recall Number
    Z-0777-2013
    Event ID
    63651
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Winco Mfg., LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 13, 2013
    Initiation Date
    September 24, 2012
    Classification Date
    February 4, 2013
    Termination Date
    May 23, 2013
    Address
    5516 SW 1st Ln, N/A, Ocala, FL, 34474-9307, United States

    Description

    PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012 A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.

    Reason

    The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.

    Code Info

    Model 5400. Serial numbers: 540100017, 540100020, 540100063, 540100160, 540100161, 540100162, 540100062, 540100103, 540100104, 540100105, and 540100106.

    Distribution

    Nationwide Distribution including CA, FL, IL, MA, MD, MN, NM, NY, OH, OK, and TX.

    Quantity

    95 units (all models)