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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00173-1
Product Name/Description Cure Sleeve (a dental barrier sleeve for curing light to prevent cross contamination)

Part Numbers: 4513C or 4513-1

Kit/Refill/Syringe Lot Numbers: 201403010110

ARTG Number: 161520
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 2/03/2015
Responsible Entity Kerr Australia Pty Ltd
Reason/Issue Kerr Corporation received complaints that cases of Cure Sleeves labelled with part number 4513 contained inner boxes with part number 4500.

There is a low risk associated with the use of this product because the smaller sleeve size is unlikely to able to be applied to the larger tips. If the product is used; there would be a remote potential for cross contamination due to the tearing of the sleeve.
Recall Action Recall
Recall Action Instructions Kerr Corporation is contacting users to Recall affected units from the Market. This action has been closed-out on 15/07/2016.
Contact Information 1800 643 603 - Kerr Australia Customer Care