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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00767-1
Product Name/Description	Alaris System Syringe Module Model Number: 8110 Material Number: 10930269 ARTG Number: 175353
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	21/08/2015
Responsible Entity	CareFusion Australia 316 Pty Ltd
Reason/Issue	CareFusion has received service reports of a channel error on the Alaris System Syringe module model 8110. A channel error is displayed on the syringe module in association with an audible and visual alarm on the attached PC Unit (error code 351.6740); once cleared on the PCU the Syringe module remains unresponsive to key presses. This error could occur during an infusion causing an interruption of infusion. Whilst connected to an Alaris System PCU at the time of error, upon power down and reattachment to any other module the PCU will continue to function as expected, there is no fault or flow on effect to the PCU module.
Recall Action	Recall for Product Correction
Recall Action Instructions	CareFusion will adjust the syringe drive train assembly on the affected units and replace, if required. This action has been closed-out on 06/09/2016.
Contact Information	02 9624 9013 - CareFusion