Events

Vascutek RVOT Elan Biplex Conduit 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Vascutek 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
    17011
  • 사례 시작날짜
    2014-07-16
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • 원인
    Manufacturer provides a high temperature cautery with each gelweave and thoraflex hybrid product and a low temperature cautery with each biovalsalva stentless biplex , stented biovalsalva biplex and rvot elan biplex conduit. these cauteries are used to cut and trim the graft. manufacturer has decided to stop supplying the cautery with these product packs due to the cautery battery having a shorter shelf life than the vascutek graft product. manufacturer will update the ifu, removing the reference to the inclusion of a catery with thes products., manufacturer will not be recalling any product as there is negligible rsk to users and patients.
  • 조치
    Instructions for use to be updated

Device

Vascutek RVOT Elan Biplex Conduit
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: all lots
  • Manufacturer
    Vascutek Ltd

Manufacturer

Vascutek Ltd