Print version of this report
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