Events

Debriflo Ultrasonic Wound Irrigation Hand-piece 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Debriflo 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-2016-RN-01165-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-09-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01165-1
  • 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
    It has been found that the current ifu includes an incorrect cleaning and sterilisation procedure. the ifu (version 14) has been updated to include the new validated cleaning and sterilisation instructions, including the use of a new cleaning solution and wipes, specific dilution directions and contact times, specific lumen flushing instructions and changes to the sterilisation temperature and time.
  • 조치
    Debriflo is providing users with a copy of the revised IFU (Version 14) with the new cleaning and sterilisation instructions.

Device

Debriflo Ultrasonic Wound Irrigation Hand-piece
  • 모델명 / 제조번호(시리얼번호)
    Debriflo Ultrasonic Wound Irrigation Hand-pieceAll lot numbers affectedARTG Number: 265127
  • Manufacturer
    Debriflo Pty Ltd

Manufacturer

Debriflo Pty Ltd
  • Source
    DHTGA