Events

Chlorhexidine 0.5% in Alcohol 70% 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Advanced Pharmaceuticals 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-2013-RN-00187-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2013-02-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00187-1
  • 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
    A precipitate was located in the chlorhexidine 0.5% in alcohol 70% solution. testing of other bottles in the same batch found the precipitate present in all bottles tested. in addition a colour variation in darkness of the pink solution was observed between these tested bottles. this colour variation corresponded with the amount and size of the particulate matter in the solution (ie darker colour solution particles were less and smaller, and in lighter colour solutions the particles were larger).This recall action was carried out prior to approval of the recall strategy by the tga.
  • 조치
    Advanced Pharmaceuticals has recalled affected batches from distributors and hospitals.

Device

Chlorhexidine 0.5% in Alcohol 70%
  • 모델명 / 제조번호(시리얼번호)
    Chlorhexidine 0.5% in Alcohol 70%Batch numbers: B04001 and B04003ARTG number: 177526
  • Manufacturer
    Advanced Pharmaceuticals Pty Ltd

Manufacturer

Advanced Pharmaceuticals Pty Ltd
  • Source
    DHTGA