BEUDAMED
    FDA Enforcement Class II Terminated

    Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.

    Recall: Z-1019-2015 · Reported February 4, 2015

    Enforcement

    Recall Number
    Z-1019-2015
    Event ID
    70141
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sunrise Medical (US) LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 4, 2015
    Initiation Date
    December 19, 2014
    Classification Date
    January 27, 2015
    Termination Date
    March 10, 2015
    Address
    2842 Business Park Ave, N/A, Fresno, CA, 93727-1328, United States

    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.

    Code Info

    Serial numbers: RZ-006261, RX-009856, RZ-005964

    Distribution

    Nationwide Distribution in the states of CO and ME.

    Quantity

    3