Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product...
Sunrise Medical (US) LLC began a recall of Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0453-2014
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Sunrise Medical, Inc.
- 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.
- Product code
- IOR Wheelchair, Mechanical
- 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.
- Root cause tag
- manufacturing process
- FDA root cause
- 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.
- Product codes and 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 ,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.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0453-2014 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
