Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assistin
Summary
The FDA issued a Class II for Zippie Voyage, early intervention stroller - Product Usage: is manually operated by Sunrise Medical (US) LLC. Reason: The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury..
Details
Source
Device Recall
External ID
Z-2157-2021
Action Date
2021-08-04
Status
Terminated
Category
device
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.
Lot/Code Info: Model Numbers: EIZ16; EIZ18; GTIN Number: 00016958053647 Serial Numbers: ZV1-007000-ZV1-016036; ZV18-000001-ZV18-002220; and ZV18-02062
Quantity Affected: 9,865 devices
Reason for Recall
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-08
Company
Fresno, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Sunrise Medical (US) LLC has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sunrise Medical (US) LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sunrise Medical (US) LLC have FDA actions?
Sunrise Medical (US) LLC has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2157-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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