Events

Device Recall SwanGanz CCOombo CCO/SvO2/VIP Thermodilution Catheter 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
    51492
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1242-2009
  • 사례 시작날짜
    2009-02-09
  • 사례 출판 날짜
    2009-04-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-04-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80541
  • 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
    Flow Directed Catheter - Product Code DYG
  • 원인
    Cardiac output measurements were unavailable and the following message is displayed in the vigilance monitor: "fault. cco catheter verification. use bolus mode".
  • 조치
    Edwards initiated the worldwide recall via Urgent Customer Notification letters dated February 9, 2009 and are being sent by Federal Express starting on February 10, 2009. These letters are requesting that customers cease using Swan-Ganz" Continuous Cardiac Output (CCO) Thermodilution Catheter products from the indicated lots and that they return all unused product. Edwards Lifesciences requested that the customer provide written verification of stock and identify any unused product to be returned. Questions should be directed to Technical Service at 800-822-9837.

Device

Device Recall SwanGanz CCOombo CCO/SvO2/VIP Thermodilution Catheter
  • 모델명 / 제조번호(시리얼번호)
    Lot 58617326
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- AL, AR, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Hawaii, and Puerto Rico and countries of Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, UK, Greece, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Portugal, Sweden, Colombia, Australia, and Singapore.
  • 제품 설명
    Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 746F8 || For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.
  • Manufacturer
    Edwards Lifesciences, Llc

Manufacturer

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