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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01130-1
Product Name/Description	Gelflex Sterile Eye Wash Normal Saline 10mL Ampoule Product code: 8200 Batch number: 1T2324002 Expiry Date: December 2017 ARTG Number: 151536
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	7/11/2014
Responsible Entity	Covidien Pty Ltd
Reason/Issue	Covidien Pty Ltd (Covidien), following advice from the Therapeutic Goods Administration and the manufacturer Marck Biosciences Ltd (now known as Amanta Healthcare Ltd) that batch number 1T2324002 of the below product has failed the test for sterility, is recalling this batch at the retail level. Please note that there have been no adverse events reported regarding this sterility test failure.
Recall Action	Recall
Recall Action Instructions	Covidien is requesting the customers to identify and quarantine the affected stock. Covidien will arrange for shipment pickup from the distribution centre and will provide credit note for the returned stock. This action has been closed-out on 05/12/2016.
Contact Information	1800 252 467 - Covidien Customer Service