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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00631-1
Product Name/Description	Medtronic Duet External Drainage and Monitoring System (Cerebrospinal fluid drainage system) Model Numbers: 46913 & 46914 Multiple lot numbers affected ARTG Number: 162723
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	13/06/2014
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	The patient line tubing in the affected devices may become disconnected from the patient line stopcock. Investigations undertaken by Medtronic determined that this issue was caused by a combination of using tubing that exceeded the recommended shelf life as well as the cleaning process of the tubing during assembly. Disconnection of the patient line is more likely to occur during handling of the system by a healthcare professional.
Recall Action	Recall
Recall Action Instructions	Medtronic is advising their customers to cease use of the affected product and return any unused units. If any of the potentially affected products are in use it should be verified that the connections are secure and leak free.
Contact Information	02 9857 9234 - Medtronic Regulatory Affairs