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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00432-1
Product Name/Description Extension Tubing in Refill Kits for use with Synchromed pumps

Model number: 8551

ARTG number: 133764
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 11/04/2014
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue Medtronic Australasia Pty Limited is initiating a voluntary recall for a specific lot of our Model 8551 Refill Kits. Medtronic have identified that some refill kits in the affected lot may contain an extension tubing set that is occluded. Healthcare professionals may be unable to aspirate or fill the SynchroMed pumps using one of these affected refill kits.
Recall Action Recall
Recall Action Instructions Medtronic is requesting their customers to identify and segregate devices from the affected lot. Return of stock will be organised by Medtronic Customer Service.
Contact Information 1800 668 670 - Medtronic Customer Service