Events

Zenith Branch Iliac Endovascular Graft (ZBIS) - Patient Card 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 William A Cook 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-00118-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-02-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00118-1
  • 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
    Cook medical has become aware that an incorrect patient card may have been included in the zenith branch endovascular graft - iliac bifurcation (zbis) devices supplied between november 2017 and january 2018. the device name on the incorrect patient card is zenith p-branch and the mri image artefact radius specified on the zbis patient card is slightly different from the image artefact radius on the incorrect patient card. the patient card is the only portion of the product impacted, there is no impact on the packaged device.There have been no customer complaints received to date in regards to this issue.
  • 조치
    Cook Medical is providing replacement patient cards to all affected customers.

Device

Zenith Branch Iliac Endovascular Graft (ZBIS) - Patient Card
  • 모델명 / 제조번호(시리얼번호)
    Zenith Branch Iliac Endovascular Graft (ZBIS) - Patient CardReference Part Numbers: ZBIS-12-61-41, ZBIS-12-45-41, ZBIS-12-45-58, ZBIS-12-61-58, ZBIS-10-61-58, ZBIS-10-45-41, ZBIS-10-61-41Multiple lot numbers affectedARTG Number: 138930
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd