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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.

FDA Recall Z-2158-2021 · Posted None

Recalling FirmSunrise Medical (US) LLC
Recall StatusTerminated
Product CodeINM
Date Initiated2021-07-08
Date Terminated2025-03-28
Product Quantity4,741 device

Reason for Recall

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

Firm Action

On 07/12/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification informing customers that if the seating system is not adequately attached to the stroller base, the seating system may slide off the base and fall to the ground potentially causing injury a child. The Recalling Firm will be providing a safety tether and are informing/instructing their customers to: This Safety Tether Kit will be provided free of charge to all consumers starting the week of July 12, 2021. The Safety Tether Kit will be accompanied by instructions to guide consumers through installing and using the safety tether. The attached consumer communication template letter provide the consumer with three options until their Safety Tether Kit is received and the safety tether has been installed by them: 1. Choose to stop using the ZIPPIE Voyage early intervention stroller until a Safety Tether Kit has been provided and the safety tether has been installed by the consumer. OR 2. If they can elect to continue to use the early intervention stroller (before receiving their Safety Tether Kit and having installed the safety tether) and they can order their stroller with a transit option, they can use the transit strap to securely attach the stroller seat to the stroller handle. The transit strap may function to prevent the seat, if inadequately attached to the stroller base, from falling to the ground. However, the transit strap is not intended to be a replacement for the Safety Tether Kit that we will be providing. The tether set should be installed and used once it is received. OR 3. Experienced users who do not have the transit option on their stroller and choose to continue to use the stroller (before they receive their Safety Tether Kit and have installed the safety tether), must ensure that the stroller seat is securely attached to the stroller base before every use (following the instructions shown in the Owners Manual]). These steps must be performed each and every time the seat

Root Cause

Device Design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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