|
Medical Device Recalls
Class 2 Recall
Jostra
|
|
Date Recall Initiated |
October 03, 2006
|
Date Posted |
November 07, 2006
|
Recall Number |
Z-0159-2007
|
Product |
Jostra HL-20 Heart Lung Machine - guiding pins
|
Code Information |
All HL 20 systems
Serial #s 1159,14031794,14031795, 14031796,14031797,14031798, 100155, 1345, 1363,1588, 14031765, 14031766, 1570, 1571,1593,1319,1320,1321,1322,14031774,14031775,
14031776, 1323,1324,1478,1479,14031067,14031069,10331385,1597,14021730,14031792,1459,1701,1512,1513,100035, 100036,
1034,1035, 14031045, 14031046, 14031047, 14031048,
1022,1023,1541,1559,100094,1025,1026,1032,1331,1332,
100011,100015,100016,100009,100063, 1668,1511, 1652, 1702,1454,1455, 1379,1380, 1381, 1272, 1417,1480, 1500, 1653, 14031054, 14031055,14031059, 14041074, 14041874,
1128, 1592, 100030, 100031, 100012, 100013, 1595, 1596,
14031039, 1510, 1105, 1433, 1434, 1456, 1457, 1577, 1578, 1579, 14021718, 14021719, 14041904, 100026, 14021706,
1420, 1421, 1398, 1418, 1598, J14041874,1584, 100108, 100109,14041074, JOSTRA, 1132, 100009, 100010,100130,100131, 1625, 1626, 1627, 1628, 1629, 100135, 100136, 100137, 1199, 1200, 1540, 1552, 1567, 1568,
1569, 1580, 1581, 1584, 1585, 1586, 14031040, 14031068,
14031761, 14031762, 1716, 100084, 14021716, 14041882,
100188, 1562, 1563, 100028, 100023, 14031831, 14031793, 1019, 1020, 1021, 1295, 100021, 100022, 14031777, 14031778, 14031779, 1523, 1524, 1017, 1442, 1443, 1465, 1466, 1635, 100116, 14031051, 14031052, 1507, 1508, 1509, 14031732, 100001, 100002, 100061, 100062, 14031734, 14031735, 14031736, 100017, 1483, 1481, 1482, 14031056,
14031057, 1535,1536, 1537, 1538, 1539, 1547, 1548, 1549, 1550, 1551, 14031060, 14031061, 14031062, 14031063, 100219,100220, 100221, 100222, 100223, 100224, 100225, 100226, 100227, 100228, 1642, 1643, 1494, 1666, 1667, 1618, 1619, 1517, 1518, 100027, 1345
|
Recalling Firm/ Manufacturer |
MAQUET Inc.
1140 US Highway 22
Bridgewater
, New Jersey
08807-2958
|
For Addition Information Contact |
Jamie Yieh
908-947-2311
|
Reason For Recall |
The HL-20's pump head on the roller pump has four pairs of tube guide rolls that keep the tube in place in the raceway and roll along the inserted tube as the pump head turns. If dirt and other particles accumulate in the tube guide rolls, they cannot roll smoothly and finally they can get stuck.
|
Action |
An 'Important Safety Notice - Please Read Immediately' letter was sent to all US customers on 10/3/06 by FedEx Return Receipt.
|
Quantity in Commerce |
227 HL-20 base units with 545 single pumps
|
Distribution |
Worldwide
|
|
|
|
|
|