Events

Cordis OPTEASE Retreivable Vena Cava Filter 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Cordis Cashel 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
    15555
  • 사례 시작날짜
    2013-10-22
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • 원인
    A printing error has been identified on one unit of optease® retrievable vena cava filter. the orientation arrow for the femoral approach was printed in the incorrect direction. the error resulted in the filter being implanted upside down, requiring an additional percutaneous procedure to retrieve the filter. all lots of the cordis optease® retrievable vena cava filter are being removed, since it cannot be absolutely determined that no other similar printing errors occurred.
  • 조치
    Product to be returned to supplier

Device

Cordis OPTEASE Retreivable Vena Cava Filter
  • 모델명 / 제조번호(시리얼번호)
    Model: Product Code: 466F210A, Affected: All lots below lot number 15960131
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Cordis Cashel

Manufacturer

Cordis Cashel