Print version of this report
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