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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00937-1
Product Name/Description	Unitek Victory Mini Tube Lower Left Buccal Tube Pack of 5 Catalogue number: 3067-8373 Batch number: GQ9SZ-0005 ARTG Number: 99491
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	18/09/2015
Responsible Entity	3M Australia Pty Ltd
Reason/Issue	Due to Operator error, the labelling for this specific batch is incorrect. The notation on the blister lid shows the contents to be a lower right buccal tube, when the blister actually contains a lower left buccal tube. The catalogue number and batch number are correct and the outer box labelling is correct. There is no risk to the patient. The error is easily recognised by the orthodontist, upon visual inspection prior to use.
Recall Action	Recall
Recall Action Instructions	The affeted customer is requested to inspect and quarantine stock on hand prior to arranging a return for either replacement or credit. This action has been closed-out on 18/08/2016.
Contact Information	02 9498 9429 - 3M Australia