FDA Device

Jostra HL-20 Heart Lung Machine - guiding pins

Hazard

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.

What You Should Do

Remedy

An 'Important Safety Notice - Please Read Immediately' letter was sent to all US customers on 10/3/06 by FedEx Return Receipt.

Products

Jostra HL-20 Heart Lung Machine - guiding pins
Brand
MAQUET Inc.
UPC
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

Units Affected

227 HL-20 base units with 545 single pumps