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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00095-1
Product Name/Description	Aquarius Regional Citrate Anticoagulation (RCA) Haemofiltration Device Product Codes: GEF09500 All Citrate Platform 6 Devices ARTG Number: 189947
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	21/02/2014
Responsible Entity	Baxter Healthcare Pty Ltd
Reason/Issue	The manufacturer has completed a software solution to prevent the potential risk of fluid overload or fluid loss caused by repetitive clearing of the balance alarm and providing users with updated Instructions For Use (IFU).
Recall Action	Recall for Product Correction
Recall Action Instructions	Baxter is notifying their customers of this problem and advising that repeated override of the Fluid Balance Alarm may eventually result in excessive loss or gain of fluid. The cause of fluid balance alarms must be identified and the fluid rate adjusted accordingly. A software update will be provided to correct the issue. This action has been closed-out on 19/02/2016.
Contact Information	02 9848 1111 - Baxter Healthcare