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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01166-1
Product Name/Description	Relief ACP Oral Care Gel supplied separately and in Zm CH 25% Kits Relief ACP 6-Syr w/Tray Case Dom Product number: PV1609 Lot number: 14127003 Relief ACP Bulk 24 Sngl Syr Product number: PV1620 Lot number: 14141018 Zm CH 25% Kit DW 9.5% ACPF 2pk AZ Product number: 881056701531 Lot number: 14135016 Zm CH Kit No TU 2pk AZ Product number: 881057001531 Lot number:14135007 Zm CH 25% Kit DW 6% HP TU 2pk AZ Product number: 881067501531 Lot number: 14097075 ARTG: 219029
Recall Action Level	Consumer
Recall Action Classification	Class II
Recall Action Commencement Date	31/10/2014
Responsible Entity	Discus Dental Australia Pty Ltd
Reason/Issue	Discus Dental has become aware that one batch of Relief ACP Oral care gel was filled with a teeth whitening gel (6%Hydrogen Peroxide as used) in one side of double barrel syringe instead of the intended component (phosphate gel). This was due to the ingredients being mislabelled after compounding the bulk components. This lot of Relief ACP Oral care gel was also included in teeth whitening product kits.br /br /Further information can be found on the TGA website at http://www.tga.gov.au/alert/relief-acp-oral-care-gel
Recall Action	Recall
Recall Action Instructions	Philips is requesting dentists to immediately contact their patients who have provided with the affected product and advise them to immediately stop usage of the product. Dentists are also requested to discard any remaining affected product. Philips is providing replacement product at no cost to dentists/patients. This action has been closed-out on 04/04/2017.
Contact Information	1800 621 448 - Philips Customer Care Centre