HEART VENT CATHETER ATRIAL 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 EDWARDS LIFESCIENCES (CANADA) INC. 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
    49929
  • 사례 위험등급
    II
  • 사례 시작날짜
    2014-10-14
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Edwards lifesciences has identified a potential patient safety risk which may occur during the use of venting catheters. the malleable stylet which aids during insertion of the vent catheter is coated with a white plastic. the white plastic on the stylet has the potential to become damaged through interaction with the hard plastic suction adapter on the vent catheter. this can result in the disruption of the white plastic coating on the stylet. there is an increased chance of generating particulate if he stylet is withdrawn with sharp bends and/or reinserted into the vent catheter. reinsertion may lead to an increased potential for particulate to enter the vasculature. no injury has been associated with the use of this device. as a result edwards is adding warnings to the instructions for use included with the affected device models.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: E060 (Lot serial: ALL LOTS WITHIN EXPIRY); Model Catalog: PE062 (Lot serial: ALL LOTS WITHIN EXPIRY); Model Catalog: E061 (Lot serial: ALL LOTS WITHIN EXPIRY)
  • 제품 설명
    HEART VENT CATHETER ATRIAL
  • Manufacturer

Manufacturer