BEUDAMED
    FDA Enforcement Class II Terminated

    Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.

    Recall: Z-2402-2016 · Reported August 17, 2016

    Enforcement

    Recall Number
    Z-2402-2016
    Event ID
    73577
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Invacare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 17, 2016
    Initiation Date
    March 15, 2016
    Classification Date
    August 11, 2016
    Termination Date
    September 15, 2017
    Address
    1200 Taylor St, Elyria, OH, 44035-6248, United States

    Description

    Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.

    Reason

    The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials.

    Code Info

    Model #'s:1104343 & 1104345

    Distribution

    US Nationwide Distribution including DC and PR. Internationally Canada.

    Quantity

    1,011 units