Events

Device Recall Edwards Lifesciences SwanGanz Thermodilution VIP Catheters 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Edwards Lifesciences, LLC 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
    62278
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2197-2012
  • 사례 시작날짜
    2012-05-11
  • 사례 출판 날짜
    2012-08-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-06-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110084
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Catheter, flow directed - Product Code DYG
  • 원인
    The device is being recalled because the firm received multiple complaints related to passage of a j-tip guidewire when inserted through the distal lumen hub of the catheter.
  • 조치
    Edwards Lifesciences sent a "PRODUCT RECALL" letter dated May 8, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Confirmation Form was attached for customers to complete and return via fax to 1-800-422-9329. Contact Customer Service at 1-800-424-3278 for questions regarding this notice.

Device

Device Recall Edwards Lifesciences SwanGanz Thermodilution VIP Catheters
  • 모델명 / 제조번호(시리얼번호)
    59163071, 59174300, 59178366, 59233787
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Japan, EMEA (Europe, Middle East and Africa), Asia Pacific, (Hong Kong, Indonesia, Malaysia, Australia, and Taiwan, Thailand), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).
  • 제품 설명
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. || For use in patients who require hemodynamic monitoring.
  • Manufacturer
    Edwards Lifesciences, LLC

Manufacturer

Edwards Lifesciences, LLC