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U.S. Department of Health and Human Services

Class 2 Device Recall Jostra

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 Class 2 Device Recall Jostrasee related information
Date Initiated by FirmOctober 03, 2006
Date PostedNovember 07, 2006
Recall Status1 Terminated 3 on December 19, 2007
Recall NumberZ-0159-2007
Recall Event ID 36255
510(K)NumberK943803 
Product Classification Heart Lung Machine - Product Code DTQ
ProductJostra 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
FEI Number 3008355164
Recalling Firm/
Manufacturer		 MAQUET Inc.
1140 US Highway 22
Bridgewater NJ 08807-2958
For Additional Information ContactJamie Yieh
908-947-2311
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionAn 'Important Safety Notice - Please Read Immediately' letter was sent to all US customers on 10/3/06 by FedEx Return Receipt.
Quantity in Commerce227 HL-20 base units with 545 single pumps
DistributionWorldwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = DTQ
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