Recall Z-2157-2021— Sunrise Medical (US) LLC
Class II · Terminated
Class II FDA medical device recall by Sunrise Medical (US) LLC, initiated 2021-07-08, terminated 2025-03-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Sunrise Medical (US) LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-08
- Terminated
- 2025-03-28
- Firm location
- Fresno, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.