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Manufacturers
Edwards Lifesciences Pty Ltd
Manufacturer Parent Company (2017)
Edwards Lifesciences Corporation
Source
DHTGA
12 Events
Recall of IntraClude Intra-aortic Occlusion Device
Recall of ClearSight Heart Reference Sensor
Recall of Intro-Flex Automatic Hemostasis Valve Introducer
Recall of Edwards Pressure Monitoring Kit & Set
Recall of Edwards Lifesciences Heart Reference Sensor
Recall of Edwards Fem-Flex II Femoral Arterial Cannula, sizes 8, 10 & 12 French
Recall of Edwards Lifesciences Heart Reference Sensor
Recall of Edwards Lifesciences Vent Catheter
Recall of Edwards Lifesciences Fem-Flex II Cannulae
Recall of Anastaflo Intravascular Shunt ( Carotid artery shunt)
Recall of Edwards Lifesciences Suction Wand (Used during cardiac surgery for the suction of excessive fluid from the pericardium)
Recall of Edwards Lifesciences QuickDraw Venous Cannula
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12 devices in the database
IntraClude Intra-aortic Occlusion Device
Model / Serial
IntraClude Intra-aortic Occlusion Device Model Number:ICF100This product has been supplied under SAS
Product Classification
Cardiovascular Devices
ClearSight Heart Reference Sensor
Model / Serial
ClearSight Heart Reference SensorModel Number: EVHRSAll serial numbers manufactured after December 31, 2015ARTG Number: 219809
Intro-Flex Automatic Hemostasis Valve Introducer
Model / Serial
Intro-Flex Automatic Hemostasis Valve IntroducerModel Number: I300F85Lot Number: 60377828ARTG Number: 146688
Edwards Pressure Monitoring Kit & Set
Model / Serial
Edwards Pressure Monitoring Kit & Set, Model Number: PXMK2043(used on patients requiring intravascular, intracranial, or intrauterine pressure monitoring)Lot numbers: 59994210, 60001412, 60020166 & 60030868ARTG Number: 142521
Edwards Lifesciences Heart Reference Sensor
Model / Serial
Edwards Lifesciences Heart Reference Sensor Model Number - EVHRSARTG Number - 219809
Product Classification
Cardiovascular Devices
7 more
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