Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0453-2014Class II

Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product...

Sunrise Medical, Inc. / initiated 2013-11-11 / Terminated / root cause: manufacturing process

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
FDA enforcement reports joined to recall event Z-0453-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0453-2014Class IITerminatedVoluntary: Firm initiated