Events

Basin Liner within Molnlycke ProcedurePak (surgical procedure packs) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Molnlycke Health Care 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-01042-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-10-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01042-1
  • 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
    During standard quality checking of components for use within molnycke health care procedurepak it has been found that some units of the basin liners provided in the pack have small holes in them which could be undetectable in normal use.
  • 조치
    Molnlycke Health Care is requesting their customers to remove the affected basin liner from the pack once the pack is opened for surgery. A sterile bowl should be used in place of the liner.

Device

Basin Liner within Molnlycke ProcedurePak (surgical procedure packs)
  • 모델명 / 제조번호(시리얼번호)
    Basin Liner within Molnlycke ProcedurePak (surgical procedure packs)ARTG entries: 133559, 133562, 133564, 133565
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd