BEUDAMED
    FDA Enforcement Class II Terminated

    Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking aid for children with disabilities, who need supplementary assistance with their daily walking. The Crocodile is available in three sizes and can be used for children between the ages of 2 to 18 years.

    Recall: Z-0503-2015 · Reported December 17, 2014

    Enforcement

    Recall Number
    Z-0503-2015
    Event ID
    69665
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Snug Seat Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 17, 2014
    Initiation Date
    August 26, 2013
    Classification Date
    December 5, 2014
    Termination Date
    December 4, 2017
    Address
    12801 E Independence Blvd, N/A, Matthews, NC, 28105-4968, United States

    Description

    Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking aid for children with disabilities, who need supplementary assistance with their daily walking. The Crocodile is available in three sizes and can be used for children between the ages of 2 to 18 years.

    Reason

    The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge.

    Code Info

    GMDN code; 31119

    Distribution

    Worldwide Distribution - U.S. Nationwide in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA & WV; International: Australia, Canada, China, Denmark, Estonia, Finland, France, Germany, Greece, Italy, Japan, New Zealand, Poland, Russia, Spain, The Netherlands, and The UK

    Quantity

    726 units