Events

OXYGEN Sterile Protection 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Danex Medical 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-00904-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-08-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00904-1
  • 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
    In a limited number of the product, oxygen sterile protection (pn: 60200), a protective cover foil that protects the transparent part of the lens hood system is not removed at some pieces. independent testing undertaken by the manufacturer has indicated that sterility of the product may not be breached despite the presence of protective cover foil,.
  • 조치
    Hospitals were advised that if they find any products with the green film still attached to the visor to put it aside and Danex Medical Pty Ltd will collect and replace the lens hoods at no charge. This action was undertaken prior to the notification to the TGA. This action has been closed-out on 11/11/2016.

Device

OXYGEN Sterile Protection
  • 모델명 / 제조번호(시리얼번호)
    OXYGEN Sterile Protection Part Number: 60200Lot/batch No.: 201401
  • Manufacturer
    Danex Medical Pty Ltd

Manufacturer

Danex Medical Pty Ltd