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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00795-1
Product Name/Description	TXR-ME (Tri-Ex Extraction Balloon with Multiple Sizing) (275 cm Length only) Serial Numbers: W3372236(1), W3376524(1), W3427509(2), W3406080(1), W3388883(2), W3403192(2), W3334395(1), W3374821(1), W3376524(1), W3308765(2), W3333058(2), W3415262(2) ARTG number: 133685
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	18/07/2014
Responsible Entity	William A Cook Australia Pty Ltd
Reason/Issue	Cook Medical has received complaints that some Tri-Ex extraction balloons may not fit through endoscopes with a 2.8 mm channel. The extraction balloon is labelled for use with a 2.8 mm endoscope.
Recall Action	Recall
Recall Action Instructions	Cook medical is requesting their customers to review their stock for the affected lot numbers and quarantine any affected product in preparation for return. This action has been closed-out on 03/06/2016.
Contact Information	1800 777 222 - William A. Cook Australia Pty Ltd