Events

Cordis S.M.A.R.T. Flex Vascular Stent System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Cardinal Health Australia 503 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-2017-RN-01446-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01446-1
  • 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
    Cordis has determined that certain lots of the s.M.A.R.T. flex vascular stent system have a potential for cracked luer hubs, due to a manufacturing error.The luer hub is used to inject contrast/saline during procedure preparation, prior to insertion of the stent system into the patient. a cracked hub could result in leakage of saline, or in the worst case, inability to flush the outer sheath of the catheter. the potential medical consequence would be a delay in device preparation, resulting in the need to prepare a replacement device for use. cordis does not anticipate any other patient impact.
  • 조치
    Cordis is advising users to inspect stock and quarantine any remaining units of the affected product for return.

Device

Cordis S.M.A.R.T. Flex Vascular Stent System
  • 모델명 / 제조번호(시리얼번호)
    Cordis S.M.A.R.T. Flex Vascular Stent SystemMultiple Lot Numbers and SKU CodesARTG Number: 223910
  • Manufacturer
    Cardinal Health Australia 503 Pty Ltd

Manufacturer

Cardinal Health Australia 503 Pty Ltd