Events

Intro-Flex Automatic Hemostasis Valve Introducer 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Edwards Lifesciences 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-01488-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-12-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01488-1
  • 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
    This recall involves an introducer sheath that was found to be out of specification. if the sheath inner diameter is too small, the clinician may have difficulty inserting the dilator or catheter into the introducer. this will cause a procedural delay as the clinician will need to change out the device over a guidewire with a minimal delay in treatment.There have been no injuries as a result of this issue.
  • 조치
    Edwards is advising users to inspect stock and quarantine any remaining units of the affected lot. Affected units can be returned to Edwards.

Device

Intro-Flex Automatic Hemostasis Valve Introducer
  • 모델명 / 제조번호(시리얼번호)
    Intro-Flex Automatic Hemostasis Valve IntroducerModel Number: I300F85Lot Number: 60377828ARTG Number: 146688
  • Manufacturer
    Edwards Lifesciences Pty Ltd

Manufacturer

Edwards Lifesciences Pty Ltd