Z-2157-2021 Class II Terminated

Recalled by Sunrise Medical (US) LLC — Fresno, CA

Recall Details

Product Type
Devices
Report Date
August 4, 2021
Initiation Date
July 8, 2021
Termination Date
March 28, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9,865 devices

Product 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 for Recall

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

Distribution Pattern

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.

Code Information

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