Events

Recall of Relief ACP Oral Care Gel supplied separately and in Zm CH 25% KitsRelief ACP 6-Syr w/Tray Case Dom

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Discus Dental Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2014-RN-01166-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01166-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

Relief ACP Oral Care Gel supplied separately and in Zm CH 25% KitsRelief ACP 6-Syr w/Tray Case Dom
  • Model / Serial
    Relief ACP Oral Care Gel supplied separately and in Zm CH 25% KitsRelief ACP 6-Syr w/Tray Case DomProduct number: PV1609Lot number: 14127003Relief ACP Bulk 24 Sngl SyrProduct number: PV1620Lot number: 14141018Zm CH 25% Kit DW 9.5% ACPF 2pk AZProduct number: 881056701531Lot number: 14135016Zm CH Kit No TU 2pk AZProduct number: 881057001531Lot number:14135007Zm CH 25% Kit DW 6% HP TU 2pk AZProduct number: 881067501531Lot number: 14097075ARTG: 219029
  • Manufacturer
    Discus Dental Australia Pty Ltd

Manufacturer

Discus Dental Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA