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U.S. Department of Health and Human Services

Class 2 Device Recall Sunrise Brand Zippie Voyage

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 Class 2 Recall
Sunrise Brand Zippie Voyage
see related information
Date Posted December 05, 2013
Recall Status1 Terminated on March 18, 2014
Recall Number Z-0453-2014
Recall Event ID 66896
Premarket Notification
510(K) Number
K123975 
Product Classification Wheelchair, Mechanical - Product Code IOR
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.
Code Information 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 ,ZV-001735 ,ZV-001463 ,ZV-001638 ,ZV-001580 ,ZV-001695 ,ZV-001726 ,ZV-001443 ,ZV-001474 ,ZV-001486 ,ZV-001508 ,ZV-001598 ,ZV-001606 ,ZV-001608 ,ZV-001692 ,ZV-001696 ,ZV-001782 ,ZV-001619 ,ZV-001664 ,ZV-001424 ,ZV-001433 ,ZV-001451 ,ZV-001457 ,ZV-001493 ,ZV-001512 ,ZV-001516 ,ZV-001543 ,ZV-001564 ,ZV-001581 ,ZV-001590 ,ZV-001602 ,ZV-001613 ,ZV-001641 ,ZV-001667 ,ZV-001671 ,ZV-001668 ,ZV-001680 ,ZV-001679 ,ZV-001684 ,ZV-001751 ,ZV-001593 ,ZV-001756 ,ZV-001535 ,ZV-001470 ,ZV-001539 ,ZV-001565 ,ZV-001624 ,ZV-001662 ,ZV-001752 ,ZV-001753 ,ZV-001647 ,ZV-001670 ,ZV-001704 ,ZV-001747 ,ZV-001660 ,ZV-001681 ,ZV-001783 ,ZV-001431 ,ZV-001434 ,ZV-001447 ,ZV-001482 ,ZV-001524 ,ZV-001550 ,ZV-001553 ,ZV-001586 ,ZV-001677 ,ZV-001734 ,ZV-001750 ,ZV-001770 ,ZV-001774 ,ZV-001784 ,ZV-001632 ,ZV-001459 ,ZV-001533 ,ZV-001518 ,ZV-001541 ,ZV-001538 ,ZV-001620 ,ZV-001467 ,ZV-001454 ,ZV-001546 ,ZV-001566 ,ZV-001477 ,ZV-001705 ,ZV-001505 ,ZV-001718 ,ZV-001719 ,ZV-001504 ,ZV-001609 ,ZV-001762 ,ZV-001724 ,ZV-001573 ,ZV-001600 ,ZV-001665 ,ZV-001694 ,ZV-001745 ,ZV-001517 ,ZV-001636 ,ZV-001582 ,ZV-001597 ,ZV-001612 ,ZV-001623 ,ZV-001439 ,ZV-001710 ,ZV-001754 ,ZV-001771 ,ZV-001510 ,ZV-001513 ,ZV-001523 ,ZV-001540 ,ZV-001599 ,ZV-001601 ,ZV-001640 ,ZV-001661 ,ZV-001699 ,ZV-001727 ,ZV-001766 ,ZV-001441 ,ZV-001764 ,ZV-001506 ,ZV-001744 ,ZV-001715 ,ZV-001757 ,ZV-001571 ,ZV-001674 ,ZV-001655 ,ZV-001414 ,ZV-001633 ,ZV-001732 ,ZV-001458 ,ZV-001509 ,ZV-001693 ,ZV-001547 ,ZV-001551 ,ZV-001639 ,ZV-001686 ,ZV-001725 ,ZV-001466 ,ZV-001649 ,ZV-001700 ,ZV-001438 ,ZV-001588 ,ZV-001730 ,ZV-001529 ,ZV-001530 ,ZV-001591 ,ZV-001626 ,ZV-001469 ,ZV-001468 ,ZV-001576 ,ZV-001579 ,ZV-001587 ,ZV-001596 ,ZV-001630 ,ZV-001689 ,ZV-001707 ,ZV-001713 ,ZV-001723 ,ZV-001736 ,ZV-001738 ,ZV-001410 ,ZV-001690 ,ZV-001484 ,ZV-001616 ,ZV-001729 ,ZV-001765 ,ZV-001556 ,ZV-001452 ,ZV-001478 ,ZV-001637 ,ZV-001657 ,ZV-001642 ,ZV-001651 ,ZV-001525 ,ZV-001522 ,ZV-001548 ,ZV-001698 ,ZV-001584 ,ZV-001739 ,ZV-001741 ,ZV-001622 ,ZV-001697 ,ZV-001743 ,ZV-001760 ,ZV-001678 ,ZV-001527 ,ZV-001528 ,ZV-001721 ,ZV-001788 ,ZV-001605 ,ZV-001572 ,ZV-001446 ,ZV-001549 ,ZV-001748 ,ZV-001409 ,ZV-001703 ,ZV-001644 ,ZV-001708 ,ZV-001444 ,ZV-001473 ,ZV-001645 ,ZV-001442 ,ZV-001552 ,ZV-001648 ,ZV-001787 ,ZV-001437 ,ZV-001643 ,ZV-001688 ,ZV-001706 ZV-001611.
Recalling Firm/
Manufacturer
Sunrise Medical (US) LLC
2842 N Business Park Ave
Fresno, California 93727-1328
For Additional Information Contact Laurie H. Roberts
559-294-2395
Manufacturer 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 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action 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.
Quantity in Commerce 316 units in US, 29 units international
Distribution Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Hong Kong, and China.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IOR and Original Applicant = SUNRISE MEDICAL
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