Events

Device Recall Proplege Coronary Sinus 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
    64221
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1322-2013
  • 사례 시작날짜
    2013-01-25
  • 사례 출판 날짜
    2013-05-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115620
  • 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, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • 원인
    Edwards lifesciences is recalling certain proplege coronary sinus catheter, model pr9 due to confirmed reports of blood leakage through the hemostasis valve in the introducer that is kitted with the catheter.
  • 조치
    Edwards Lifesciences sent an Urgent Field Safety Notice letter dated February 1, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review entire inventory for the affected product, quarantine and return to Edwards. Contact Customer Services at 800-424-3278 for any question, to obtain a Returned Goods Authorization number and replacement product.

Device

Device Recall Proplege Coronary Sinus Catheter
  • 모델명 / 제조번호(시리얼번호)
    Model PR9, lot numbers: 59385159, 59385164, 59385204, 59398000, 59398006, 59398008, 59400402, 59423199, 59423200, 59385159, 59385164, 59385204, 59398000, 59398006.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide including the states of: MD, NY, PA, CA, FL, AZ, AL, TX, VA, OH, MO, NC, GA, TN, CO, OR, SC, ME, IL, HI, NJ, WA, WI, CT, KY, LA and Canada.
  • 제품 설명
    Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. || Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter provides retrograde cardioplegia during cardiopulmonary by-pass surgery.
  • Manufacturer
    Edwards Lifesciences, LLC

Manufacturer

Edwards Lifesciences, LLC