Events

Device Recall SwanGanz Thermodilution VIP Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Edwards Lifesciences Technology SARL 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
    36934
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0338-2007
  • 사례 시작날짜
    2006-11-27
  • 사례 출판 날짜
    2007-01-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49588
  • 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
    Thermodilution VIP Catheter - Product Code DYG
  • 원인
    Misbranding-one lot of swan-ganz thermodilution vip catheters, model 831hf75, lot 246hc197 was labeled with different model information (831f75) on the edge label . the edge label states the model is 831f75 which incorrectly indicates that product does not contain an antimicrobial heparin coating. (the tray lid label correctly states the model is 831hf75, containing the heparin coating).
  • 조치
    Edwards initiated the recall in the US by sending a Customer Letter by Federal Express on November 28, 2006, along with a Q&A; to their customers Service and Direct Customers to facilitate the uderstanding of the recall and the request for verification and return of all unused product.

Device

Device Recall SwanGanz Thermodilution VIP Catheter
  • 모델명 / 제조번호(시리얼번호)
    Model Number: 831FH75 Lot Number: 246HC197 Expiration Date: Feb. 2008
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution ----USA and countries of Columbia and Venezuela.
  • 제품 설명
    Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75
  • Manufacturer
    Edwards Lifesciences Technology SARL

Manufacturer

Edwards Lifesciences Technology SARL
  • 제조사 주소
    Edwards Lifesciences Technology SARL, Hwy # 402 North, Km 1.4, International Industrial Park, Anasco PR 00610-1576
  • Source
    USFDA