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Devices
Jostra
Model / Serial
Article # 923391 The affected HL-20 base units include S/Ns 100001 through 100240. Hand cranks shipped between the dates of 8/15/05 to 8/14/06 have the potential to be defective. Serial #s100155, 1025, 1026, 1032, 1331, 1332, 100011, 100015, 100016, 100017, 1272, 1417, 1480, 1500, 1653, 14031054, 14031055, 14031059, 14041074, 14041874, 100012, 100013, J14041874, 1584, 100108, 100109, 14041074, JOSTRA, 100009, 100010, 100130, 100131, 1625, 1626, 1627, 1628, 1629, 100135, 100136, 100137, 14031040, 14031068, 100188, 1019, 1020, 1021, 1295, 100021, 100022, 100116, 14031051, 14031052, 1507, 1508, 1509, 100017, 100219, 100220, 100221, 100222, 100223, 100224, 100225, 100226, 100227, 100228.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
worldwide
Product Description
Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank
Manufacturer
MAQUET Inc.
1 Event
Recall of Jostra
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Manufacturer
MAQUET Inc.
Manufacturer Address
MAQUET Inc., 1140 US Highway 22, Bridgewater NJ 08807-2958
Source
USFDA
12 devices with a similar name
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Jostra open heart catheter N
Model / Serial
Product Description
Aortic cannula
Manufacturer
Getinge Group Japan Co., Ltd.
Device Recall Jostra Heater Cooler
Model / Serial
Article number: 0704629 Serial numbers: 101006, 101007, 101008, 101009, 101010, 101011, 101013, 101015, 101016, 101018, 101019, 101020, 101022, 101023, 101024.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Hospitals in CA, NC, FL, WY, NY and WV.S
Product Description
Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine
Manufacturer
MAQUET Inc.
Jostra HL30
Model / Serial
Product Description
Surgical equipment/ Anaesthesia
Manufacturer
Maquet
Jostra HL20
Model / Serial
917741, 917751, 703693, 703695, 703761, 703763 | all
Product Description
MD: Heart-lung bypass system
Manufacturer
Maquet Critical Care AB
Jostra HL30
Model / Serial
952201 | all
Product Description
MD: Heart-lung bypass system
Manufacturer
Maquet Critical Care AB
7 more
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