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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00119-1
Product Name/Description	Alaris SmartSite Needlefree Connector Model Number: 2000E Batch Numbers: 13106451, 13046117, 13106355, 13045933, 13106754, 13086446, 13106753, 13096012, 13115734, 13095674, 13115872, 13095579, 13105584, 13095237, 13095913, 13106096, 13095914, 13095675, 13096488, 13106260 & 13106497 ARTG Number: 189737
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	27/02/2014
Responsible Entity	CareFusion Australia 316 Pty Ltd
Reason/Issue	CareFusion has identified potential risks with model code 2000E and lot numbers listed due to connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. Leakage may also be observed if the connector disconnects from the female luer during infusion. An inability to disconnect may require replacement of a line.
Recall Action	Recall
Recall Action Instructions	Carefusion is requesting users to segregate and return unused stock of connectors with polycarbonate housing to Carefusion. Polycarbonate materials were introduced because they provide more resistance to isopropyl alcohol than the acrylic housing hub. Now that the 2000E polycarbonate version will no longer be available, please remind staff that when accessing the valve, remember to Swab The Hub every time, do not swab the whole body of the device and take care to follow instructions during connection and disconnection of the SmartSite connector.
Contact Information	02 9624 9013 - CareFusion