Events

FemoSeal Vascular Closure System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Terumo 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-2017-RN-01092-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-08-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01092-1
  • 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
    Terumo medical corporation has received an increase in device related malfunction complaints for femoseal vascular closure systems. specifically, after the deployment of the inner locking disc, the complaints state that the button will not spring back as intended, preventing the outer locking disc from deploying and completing the procedure.An investigation by terumo has identified that the internal suture becomes entrapped as a result of operator miss-assembly during device manufacture and that this issue then only becoming visible midway through device deployment.
  • 조치
    1. Review the urgent medical device recall notification and distribute to all staff working with this equipment. 2. Inform any facilities that may have received this product of the recall action. 3. Quarantine all product in the affected population, record the lot number and quantity on the Customer Response Form supplied with the Customer Letter 4. Place quarantined product in a secure location for return to Terumo Australia Regulatory Affairs Department. 5. Package and return all affected product via courier

Device

FemoSeal Vascular Closure System
  • 모델명 / 제조번호(시리얼번호)
    FemoSeal Vascular Closure SystemAll non-expired productProduct Code: C11202Multiple Lot NumbersARTG Number: 263892
  • Manufacturer
    Terumo Australia Pty Ltd

Manufacturer

Terumo Australia Pty Ltd