Events

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

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Discus Dental Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2014-RN-01166-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-10-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01166-1
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA