BEUDAMED
    FDA Recall 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 · Initiated March 15, 2016

    Recall

    Recall Number
    Z-2402-2016
    Event Number
    73577
    Firm
    Invacare Corporation
    FEI Number
    1525712
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 15, 2016
    Terminated
    September 15, 2017
    Address
    1200 Taylor St, Elyria, OH, 44035-6248

    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.

    Action

    Invacare sent an Urgent Medical Device Recall letter dated May 12, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call Invacares recall support line at (877) 413-6008, Monday Friday, 8 a.m. 5 p.m. EST, for assistance.

    Distribution

    US Nationwide Distribution including DC and PR. Internationally Canada.

    Quantity

    1,011 units