Events

Device Recall Edwards LifeStent FlexStar Biliary Stent System 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
    46679
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1270-2008
  • 사례 시작날짜
    2007-12-05
  • 사례 출판 날짜
    2008-07-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67986
  • 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
    Biliary catheter and accessories - Product Code FGE
  • 원인
    Incorrect expiration date: products were labeled with an incorrect shelf-life expiration date. therefore, the sterility of the device may be compromised.
  • 조치
    Consignees were notified by an Urgent Product Recall letter sent on 12/5/07. The letter instructed users to return any affected product to the recalling firm for replacement products. The letter also advised users that the likelihood of patient complications is extremely low for products that have already been implanted in patients. Users were requested to return a confirmation form after checking the inventory for any affected products. For additional information, contact 1-949-250-3779.

Device

Device Recall Edwards LifeStent FlexStar Biliary Stent System
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: FR6H0159
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100603CD; Edwards Lifesciences LLC, Irvine, CA 92614.
  • Manufacturer
    Edwards Lifesciences, Llc

Manufacturer

Edwards Lifesciences, Llc
  • 제조사 주소
    Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA