BEUDAMED
    FDA Enforcement Class II Terminated

    Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.

    Recall: Z-2157-2021 · Reported August 4, 2021

    Enforcement

    Recall Number
    Z-2157-2021
    Event ID
    88257
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sunrise Medical (US) LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 4, 2021
    Initiation Date
    July 8, 2021
    Classification Date
    July 28, 2021
    Termination Date
    March 28, 2025
    Address
    2842 N Business Park Ave, N/A, Fresno, CA, 93727-1328, United States

    Description

    Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.

    Reason

    The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.

    Code Info

    Model Numbers: EIZ16; EIZ18; GTIN Number: 00016958053647 Serial Numbers: ZV1-007000-ZV1-016036; ZV18-000001-ZV18-002220; and ZV18-02062

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of United Kingdom, Germany, France, Canada, Italy, Netherlands, Poland, Czech Republic, Australia, Hong Kong, Japan, Qatar, Norway, United Arab Emirates, China, Saudi Arabia, Sweden, Switzerland, Spain, Indonesia, India, Singapore, Bahrain and Israel.

    Quantity

    9,865 devices