Events

Back Table Cover supplied in a limited range of Operating Room Packs 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Plus 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-2015-RN-00686-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-07-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00686-1
  • 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
    Itl healthcare has identified an issue as a result of one customer complaint with the standard back table cover from one supplier. once the outer bag is opened the back table cover serves as a trolley cover. in some instances the sterility will be breached if the permeability of the back table cover is challenged. this issue was not observed in all batches; the extent is still under investigation.
  • 조치
    ITL Healthcare is providing workaround instructions to be undertaken during surgery setup. Alternative Back Table Covers will be provided free of charge to facilitate the workaround. Should the hospital be unable to implement the workaround, ITL will provide replacement Operating Room Packs. This action has been closed-out on 15/08/2016.

Device

Back Table Cover supplied in a limited range of Operating Room Packs
  • 모델명 / 제조번호(시리얼번호)
    Back Table Cover supplied in a limited range of Operating Room Packs
  • Manufacturer
    Plus Medical Pty Ltd

Manufacturer

Plus Medical Pty Ltd