Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufact
FDA device recall Z-0453-2014 · posted 2013-12-05 · Terminated
Recall details
- Recalling firm
- Sunrise Medical (US) LLC
- Reason for recall
- There is a remote possibility for the plastic latch to deform over the lifetime of use. When this happens there is the possibility for the seat to become dislodged from the base. And when not using the positioning strap, there is a risk that the occupant could slide out of the seat and sustain injury.
- Action taken
- Urgent Medical Device Field correction letters were sent to Sunrise Suppliers/Dealers and Zippie Customers on November 2013 by first class mail. Foreign notification was supplied to suppliers and regulatory affairs director in Canada.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IOR
- Quantity affected
- 316 units in US, 29 units international
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Hong Kong, and China.
- Date initiated
- 2013-11-11
- Date posted
- 2013-12-05
- Date terminated
- 2014-03-18
- Location
- Fresno, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| QUICKIE & ZIPPIE SERIES (K123975) | Sunrise Medical | 2013-08-16 |