Events

EnCor Probes (used for breast biopsies) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bard 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-2016-RN-00490-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00490-1
  • 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
    Bard peripheral vascular (bpv) has confirmed that the affected lot numbers may be at risk of having an incorrect sample trap assembly. a portion of the affected lots may contain units with incorrect sample trap assemblies affixed to the probe inside the product tray (a lateral assembly instead of an upright assembly). the labelling on the outer product carton and inside packaging tray is correct. specifically, the issue is that the incorrect sample trap assembly contains shorter vacuum tubing and no clear tray cover.The potential harm associated with attempting to use this device labelled for upright use may result in the sample trap assembly being filled with fluid during use and when removing the sample collection tray (basket), the sample(s) may fall out of the collection tray because of the lack of a cover.
  • 조치
    Bard is advising users to inspect the affected lots before use to ensure the correct trap assembly is affixed to the probe. This action has been closed-out on 30/01/2017.

Device

EnCor Probes (used for breast biopsies)
  • 모델명 / 제조번호(시리얼번호)
    EnCor Probes (used for breast biopsies)Biopsy Probe – 10g VerticalEnd Item Code: ECP0110GVLot Numbers: VT14G0223, VT15F0266, VT15G0345, VT15K0439, VT15L0482, VT15M0572Biopsy Probe – 12g VerticalEnd Item Code: ECP0112GVLot Number: VT15E0244ARTG Number: 154530
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd