Events

Hypochlorite 1% Solution & Hypochlor 1% Solution 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Dentalife 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-2015-RN-01222-2
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-12-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01222-2
  • 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
    It has come to dentalife's attention that there is a contamination risk in two batches of sodium hypochlorite solution small particles of black matter have been observed floating in several 1.25l bottles of the solution. the issue has been investigated and the material is suspected to be particles of a food grade grease used to lubricate the volumetric filling device as part of the manufacturing process.
  • 조치
    Dentalife is advising users to discard affected stock for replacement. This action has been closed-out on 29/08/2016.

Device

Hypochlorite 1% Solution & Hypochlor 1% Solution
  • 모델명 / 제조번호(시리얼번호)
    Hypochlorite 1% Solution & Hypochlor 1% SolutionProduct Codes: DL0403, HPH125 (1.25L) and DL0401 (500mL)Batch Numbers: 2356 and 4209Expiry Dates: 06/17 and 09/17ARTG Number: 160242
  • Manufacturer
    Dentalife Australia Pty Ltd

Manufacturer

Dentalife Australia Pty Ltd