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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01631-1
Product Name/Description	Smart Site Add-on Bag Access Device Model Number: 10013365 Lot Numbers: 15055702, 15056299, 15056618, 15065645, 15075740, 15077085, 15085031, 15086107, 15095014, 15095411, 15106928, 15116928, 15126069, 15127413, 16015324, 16015607 ARTG Number: 189737
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	16/12/2016
Responsible Entity	CareFusion Australia 316 Pty Ltd
Reason/Issue	Reports have been received of leakages between the spike port and the drip chamber spike of the Smart Site Add-On Bag Access Device. Separation and leakage between the spike port and the drip chamber spike may occur during infusion. To date, there have been no reports of serious injury or death in Australia associated with the separation or leaks.
Recall Action	Recall
Recall Action Instructions	CareFusion is advising customers to quarantine affected stock. Customer Service will then arrange for the pick-up of the affected stock and issue a replacement or an account credit. This action has been closed-out on 21/03/2018.
Contact Information	02 9624 9033 - CareFusion