BEUDAMED
    FDA Enforcement Class II Terminated

    DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-handle, Three-position lock, Over-lap tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

    Recall: Z-1116-2014 · Reported March 5, 2014

    Enforcement

    Recall Number
    Z-1116-2014
    Event ID
    67377
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Winco Mfg., LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 5, 2014
    Initiation Date
    September 6, 2013
    Classification Date
    February 26, 2014
    Termination Date
    December 30, 2014
    Address
    5516 SW 1st Ln, Ocala, FL, 34474-9307, United States

    Description

    DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-handle, Three-position lock, Over-lap tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

    Reason

    A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.

    Code Info

    Model(s) 5271, 5281. Serial numbers: 527A101756 thru 527A101816, 528A100187 thru 528A100199.

    Distribution

    Worldwide Distribution - USA nationwide including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kanas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Puerto Rico and Internationally to the country of Canada.

    Quantity

    369 units (all models)