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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00497-1
Product Name/Description	GLUMA Desensitizer Power Gel ( Polymer based dental bonding agent) Article Numbers: 66043451, 66052803 Syringe Lot Numbers: 10103, 10104 Assortment Lot Numbers: 42, 43, 44, 45, 46, 47, 48, 49, 50, 51 Expiry Date: 09/2015 ARTG number: 92714
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	7/05/2014
Responsible Entity	Heraeus Dental Australia Pty Ltd
Reason/Issue	The manufacturer have received reports about single syringes of these LOT showing more than usual jerky extrusion behaviour. In one case this led to a fluid ejection from the syringe in front of a hygienist when pushing harder on the plunger rod outside the mouth. If uncontrolled fluid ejection from the syringe occurs, especially the dental patient could be exposed to the gel reaching the mucosa, the face or even the eyes causing irritation, chemical burns and blistering of the tissues which is a medically reversible condition.
Recall Action	Recall
Recall Action Instructions	Customers are advised to search their inventory and immediately quarantine any GLUMA Desensitizer PowerGel stock with the affected lot numbers. Stop using the affected products and return the product to the distributor. This action has been closed-out on 11/02/2016.
Contact Information	02 8422 6100 - Heraeus Dental Australia