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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