Events

Single Use Instruments including Scissors, forceps, and suckers 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Thermo Fisher Scientific Australia 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-2018-RN-00153-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-02-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00153-1
  • 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
    Thermo fisher scientific received a labelling concern that a sterile instrument used during surgical procedures was not labelled as a single use instrument and that there could be the possibility of reuse.The devices affected are manufactured as single use instruments, and are safe for use as single use instruments. when used as single use instruments the devices do not pose a risk to human health and are safe to use within the scope of their artg inclusion.
  • 조치
    Thermo Fisher Scientific is advising users to keep the notification in a prominent position. The manufacturer is currently working with their notified body on a scope extension but due to the time required to complete this, a resolution may not be achieved for 6 to 12 months.

Device

Single Use Instruments including Scissors, forceps, and suckers
  • 모델명 / 제조번호(시리얼번호)
    Single Use Instruments including Scissors, forceps, and suckersMultiple products affectedAll lots affected ARTG Numbers: 296281, 296277, 296279, 296278, 296276, 296280, 296240, 296260, 296315
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd