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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01153-1
Product Name/Description	Alaris GP Infusion set with Back Check Valve Reference Number : 63420EB Lot Numbers: 1000079, 1000169, 1000177, 1000321 ARTG Number: 125916
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	2/09/2016
Responsible Entity	CareFusion Australia 316 Pty Ltd
Reason/Issue	The manufacturer has received an increased rate of reports citing false upstream occlusion alarm of Alaris GP sets with Back Check Valve – 63420EB. These errors have been reported at flow rates below 250mL/hour. There is a risk that a clinician will not be able to start an infusion, or the infusion may be stopped due to an alarm, potentially resulting in a delay in therapy.
Recall Action	Recall
Recall Action Instructions	BD is advising users to inspect inventory and quarantine any stocks of the affected lot numbers. Affected stock can be returned to BD for credit or replacement. This action has been closed out on 7/09/2018.
Contact Information	1800 833 372 – BD Customer Service