BEUDAMED
    FDA Recall Terminated

    Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.

    Recall: Z-1019-2015 · Initiated December 19, 2014

    Recall

    Recall Number
    Z-1019-2015
    Event Number
    70141
    Firm
    Sunrise Medical (US) LLC
    FEI Number
    2937137
    Product Code
    IOR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 19, 2014
    Posted
    January 27, 2015
    Terminated
    March 10, 2015
    Address
    2842 Business Park Ave, Fresno, CA, 93727-1328

    Description

    Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.

    Reason

    There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.

    Action

    Sunrise Medical sent an Urgent Medical Device Field Correction letters dated December 19, 2014 to the two affected distributors. The letter identified the affected product, problem and actions to be taken. For question contact Sunrise Medical Regulatory Affairs at either (559)294-2840.

    Distribution

    Nationwide Distribution in the states of CO and ME.

    Quantity

    3