Recall Z-0453-2014
Sunrise Medical (US) LLC · initiated November 11, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
Codes / lots: Serial Numbers: ZV-001563 ,ZV-001672 ,ZV-001691 ,ZV-001737 ,ZV-001740 ,ZV-001423 ,ZV-001537 ,ZV-001557 ,ZV-001604 ,ZV-001746 ,ZV-001749 ,ZV-001761 ,ZV-001669 ,ZV-001682 ,ZV-001722 ,ZV-001755 ,ZV-001711 ,ZV-001415 ,ZV-001634 ,ZV-001716 ,ZV-001615 ,ZV-001521 ,ZV-001589 ,ZV-001617 ,ZV-001618 ,ZV-001627 ,ZV-001683 ,ZV-001702 ,ZV-001763 ,ZV-001773 ,ZV-001491 ,ZV-001531 ,ZV-001534 ,ZV-001562 ,ZV-001560 ,ZV-001569 ,ZV-001575 ,ZV-001720 ,ZV-001772 ,ZV-001635 ,ZV-001659 ,ZV-001777 ,ZV-001712 ,ZV-001487 ,ZV-001526 ,ZV-001574 ,ZV-001759 ,ZV-001595 ,ZV-001555 ,ZV-001603 ,ZV-001775 ,ZV-001520 ,ZV-001485 ,ZV-001519 ,ZV-001460 ,ZV-001687 ,ZV-001515 ,ZV-001614 ,ZV-001465 ,ZV-001742 ,ZV-001767 ,ZV-001685 ,ZV-001628 ,ZV-001785 ,ZV-001407 ,ZV-001408 ,ZV-001507 ,ZV-001658 ,ZV-001663 ,ZV-001511 ,ZV-001532 ,ZV-001545 ,ZV-001778 ,ZV-001568 ,ZV-001585 ,ZV-001607 ,ZV-001631 ,ZV-001629 ,ZV-001650 ,ZV-001654 ,ZV-001675 ,ZV-001717 ,ZV-001769 ,ZV-001430 ,ZV-001570 ,ZV-001559 ,ZV-001475 ,ZV-001488 ,ZV-001489 ,ZV-001490 ,ZV-001542 ,ZV-001578 ,ZV-001583 ,ZV-001656 ,ZV-001728 ,ZV-001714 ,ZV-001652 ,ZV-001653 ,ZV-001536 ,ZV-001676 ,ZV-001355 ,ZV-001366 ,ZV-001483 ,ZV-001594 ,ZV-001701 ,ZV-001709 ,ZV-001554…
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.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-0453-2014
- Initiated
- November 11, 2013
- Posted by FDA
- December 5, 2013
- Terminated
- March 18, 2014
- Product code
- IOR – Wheelchair, Mechanical
- Quantity
- 316 units in US, 29 units international
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Hong Kong, and China.
- Recalling firm
- Sunrise Medical (US) LLC, Fresno, CA