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U.S. Department of Health and Human Services

Class 2 Device Recall Medcare Lift with Scale Medcare Lift w/Scale 600 lb Scale Hanger Assembly

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 Class 2 Recall
Medcare Lift with Scale Medcare Lift w/Scale 600 lb Scale Hanger Assembly
see related information
Date Posted April 10, 2014
Recall Status1 Open
Recall Number Z-1450-2014
Recall Event ID 67804
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
Product 400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 Scale Hanger Assembly Product Usage: The intended use is a patient hanger bar (400600) attached to a 400003 or 400013 floor lift used to lift, transfer or position clients.
Code Information Serial # 0810LS1522 0810LS1523 0910LS1524 0910LS1525 0910LS1526 0910LS1527 0910LS1528 0804LS0854 0910LS1529 0910LS1530 1010LS1532 0910LS1531 1010LS1533 1010LS1534 1010LS1535 1010LS1536 1010LS1537 1010LS1538 1010LS1539 1010LS1540 1010LS1541 1010LS1542 1010LS1543 1010LS1544 1010LS1545 1010LS1546 1010LS1547 1010LS1548 1110LS1549 1201LS1551 1210LS1550 1210LS1552 1210LS1553 1210LS1554 1210LS1555 1210LS1556 1210LS1557 0111LS1558 0111LS1561 0111LS1560 0111LS1562 0111LS1563 0111LS1564 0111LS1565 0111LS1566 0111LS1567 0111LS1559 0111LS51559 0111LS1568 0211LS1569 0211LS1570 0211LS1571 0211LS1572 0311LS1573 0311LS1575 0311LS1576 0311LS1578 0311LS1577 0311LS1579 0311LS1580 0311LS1583 0311LS1581 0311LS1582 0311LS1586 0311LS1574 0311LS1585 0311LS1587 0411LS1588 0411LS1589 0411LS1590 0411LS1591 0411LS1592 0411LS1593 0411LS1594 0511LS1597 0511LS1598 0511LS1599 0511LS1596 0511LS1600 0511LS1601 0511LS1602 0411LS1595 0511LS1603 0611LS1605 0611LS1604 0611LS1606 0611LS1607 0611LS1608 0611LS1609 0611LS1610 0611LS1611 0711LS1612 0711LS1613 0711LS1614 0711LS1615 0711LS1616 0711LS1617 0711LS1618 0711LS1619 0711LS1620 0311LS1584 0711LS1621 0711LS1622 0711LS1623 0811LS1624 0711LS1625 0811LS1625 0811LS1626 0811LS1627 0811LS1628 0811LS1629 0811LS1631 0811LS1630 0911LS1632 0911LS1633 0911LS1639 0911LS1636 0911LS1641 0911LS1642 0911LS1643 0911LS1644 0911LS1634 0911LS1637 0911LS1638 0911LS1640 0911LS1645 1011LS1647 1011LS1646 1011LS1648 1011LS1649 1011LS1650 1011LS1651 1011LS1652 1011LS1653 1011LS1655 1011LS1654 1011LS1656 1011LS1658 1011LS1657 1011LS1659 1011LS1660 1211LS1661 1211LS1662 1211LS1663 1211LS1664 1211LS1665 1211LS1666 1211LS1667 1211LS1668 1211LS1669 1211LS1670 1211LS1671 1211LS1672 1211LS1673 1211LS1674 1211LS1678 0112LS1683 0112LS1681 0112LS1682 0112LS1684 1211LS1675 1211LS1676 1211LS1677 0112LS1680 0112LS1685 0911LS1635 1211LS1679 0112LS1686 0112LS1687 0112LS1688 0112LS1689 0112LS1690 0112LS1691 0212LS1693 0212LS1694 0212LS1692 0212LS1697 0212LS1698 0212LS1699 0212LS1700 0212LS1701 0212LS1702 0312LS1703 0312LS1704 0312LS1705 0412LS1706 0412LS1707 0412LS1708 0412LS1709 0412LS1710 0412LS1711 0412LS1712 0412LS1713 0412LS1714 0412LS1715 0412LS1716 0412LS1718 0412LS1720 0412LS1721 0412LS1722 0412LS1723 0412LS1724 0412LS1725 0412LS1719 0412LS1717 0412LS1727 0412LS1728 0212LS1695 0212LS1696 0412LS1729 0412LS1730 0412LS1731 0412LS1733 0412LS1734 0412LS1735 0412LS1736 0612LS1737 0612LS1738 0612LS1739 0612LS1740 0412LS1726 0412LS1732 0612LS1741 0612LS1743 0612LS1745 0612LS1746 0712LS1747 0712LS1748 0712LS1749 0712LS1750 0612LS1742 0712LS1751 0812LS1757 0712LS1752 0812LS1753 Serial # 0610FS0633 0610FS0632 0610FS0634 0910FS0635 0910FS0636 0910FS0637 0910FS0638 0910FS0639 0910FS0640 0910FS0641 1010FS0643 1010FS0644 1010FS0645 1010FS0646 1010FS0647 1010FS0648 1010FS0649 1010FS0650 1010FS0651 1010FS0652 1010FS0653 1010FS0654 1110FS0653 1110FS655 1110FS0656 1210FS0657 1210FS0658 1210FS0659 0111FS0662 0111FS0661 0111FS0663 0111FS0664 0111FS0665 0111FS0666 0111FS0660 0310FS0624 1008FS0557 0211FS0668 0211FS0669 0211FS0670 0311FS0671 0311FS0672 0311FS0673 0211FS0667 0311FS0674 0311FS0675 0411FS0676 0411FS0677 0411FS0678 0411FS0679 0511FS0681 0511FS0682 0511FS0683 0511FS0680 0611FS0684 0611FS0687 0611FS0685 0711FS0688 0711FS0690 0611FS0686 0811FS0691 0811FS0693 0811FS0695 0911FS0697 0911FS0698 0911FS0699 0811FS0692 0911FS0696 0911FS0701 0911FS0700 0911FS0702 0911FS0703 0911FS0704 0811FS0694 0911FS0705 0911FS0707 0911FS0706 0911FS0708 1011FS0711 1011FS0712 1011FS0710 0911FS0709 0112FS0722 0112FS0723 1011FS0713 1011FS0714 1011FS0715 1011FS0716 1011FS0717 1011FS0718 1011FS0719 0112FS0724 0112FS0725 0112FS0726 0212FS0733 0212FS0727 0212FS0728 0212FS0729 0212FS0730 0212FS0731 0212FS0732 0711FS0689 0212FS0734 0212FS0735 0212FS0736 0212FS0737 0412FS0741 0412FS0744 0412FS0745 0412FS0746 0412FS0739 0412FS0740 0412FS0742 0412FS0743 0512FS0747 0512FS0748 0512FS0750 0512FS0751 0512FS0749 0412FS0738 0512FS0752 0512FS0753 0512FS0754 0512FS0755 0512FS0756 0612FS0757 0612FS0758 0612FS0759 0712FS0760 0712FS0762 0712FS0763 0812FS0766 0812FS0765 0912FS0767 0912FS0768 0912FS0769 0912FS0770 0712FS0761 1012FS0777 1012FS0775 1012FS0774 0712FS0764 0912FS0771 Serial # J811784 J811850 J857892 L2A023201 L2A023217 W28213 J811920 J857848 J857885 L2A030559 5811761 5811812 L2A029637 L2A029648 L2A029630 L2A029612 L2A030550 L2A029651 L2A023200 L2A029581 L2A023207 L2A029632 L2A029635 L2A023178 L2A023173 L2A029621 L2A023248 L2A029627 L2A029611 L2A029607 L2A029601 L2A030543 L2A029629 L2A029610 L2A023238 L2A030557 21120381 21120366 21120395 21120377 21120392 21120361 21120372 L2A029614 21120400 21120401 L2A029579 J811815 L2A023216 L2A029639 L2A029626 21130612 21134922 21130598 21153516 21153542 21120397 21163412 21163415 21163425 21163432 21163409 21163416 21163404 21173082 21163400 21134899 21173085 21153494 21163438 21173109 21189283 21189286 21134911 21134897 21163408 21153554 21153560 21153520 21134907 21134916 21153512 21189284 21189293 21153481 21153530 21173080 21226274 21226285 21153479 21153524 21226278 21226275 21233710 21153511 21173075 21153548 21153508 21134903 21134920 21233715 21134910 21233717 21233723 21226273 21134917
Recalling Firm/
Manufacturer
ErgoSafe Product LLC dba Prism Medical Services
480 University Avenue, Suite 510
Toronto, ON M5GiV2
Manufacturer Reason
for Recall
MedCare Products has determined that a number of their Floor Lifts manufactured from 9/1/2010 to 11/7/2012 do not meet MedCare's high standards. The original design includes a pin that over time and years of use may stop performing as designed and may break.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Medcare sent a Notification letter dated May 10th, 2013 to affected customers. The letter described the affected product, problem, actions to be taken and provided a replacement assembly. It instructed consignees to replace the old assembly with the new one included in the package. For questions they can contact Todd Perrine in their Technical Support Department at 952-300-2101.
Quantity in Commerce 514
Distribution USA Nationwide Distribution in the states of: CA, CO, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, NO, NE,NH,NY, ND,OH, OK, OR, PA , SD, TX, WI.
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.
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