BEUDAMED
    FDA Recall Terminated

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    Recall: Z-0453-2014 · Initiated November 11, 2013

    Recall

    Recall Number
    Z-0453-2014
    Event Number
    66896
    Firm
    Sunrise Medical (US) LLC
    FEI Number
    2937137
    Product Code
    IOR
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 11, 2013
    Posted
    December 5, 2013
    Terminated
    March 18, 2014
    Address
    2842 N Business Park Ave, Fresno, CA, 93727-1328

    Description

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    Reason

    There is a remote possibility for the plastic latch to deform over the lifetime of use. When this happens there is the possibility for the seat to become dislodged from the base. And when not using the positioning strap, there is a risk that the occupant could slide out of the seat and sustain injury.

    Action

    Urgent Medical Device Field correction letters were sent to Sunrise Suppliers/Dealers and Zippie Customers on November 2013 by first class mail. Foreign notification was supplied to suppliers and regulatory affairs director in Canada.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Hong Kong, and China.

    Quantity

    316 units in US, 29 units international