Events

Device Recall Optiflux F250NRe Hemodialyzer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fresenius Medical Care Holdings, Inc. 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
    57947
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1622-2011
  • 사례 시작날짜
    2011-02-16
  • 사례 출판 날짜
    2011-03-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-02-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97801
  • 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
    Dialyzer, High Permeability With or Without Sealed Dialysate System - Product Code KDI
  • 원인
    There is an increased risk of an internal blood leak.
  • 조치
    FMCNA notified consignees on 2/16/11 by telephone and follow-up with an Urgent FMCNA Optiflux F250NRe Recall letter via Certified Mail, return Receipt requested. The firm states in the letter that there is an increased risk of an internal blood leak affecting a small percentage of the two lots of dialyzers. They are asking customers to examine their inventory, to discontinue use, and segregate the affected product in a secure place. Customers are to contact their FMCNA Customer Service Team at 1-800-323-5188 for instructions on how to return product. Used dialyzers should not be returned. If there are any questions, Customer Service should be contacted.

Device

Device Recall Optiflux F250NRe Hemodialyzer
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers:  10HU02012, Expiration Date: 06/30/2013; and  10LU02016, Expiration Date: 09/30/2013.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA and Canada.
  • 제품 설명
    Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E, Advanced Fresenius Polysulfone. || Intended for use as an artificial kidney system to the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration and hemodiafiltration.
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.

Manufacturer

Fresenius Medical Care Holdings, Inc.
  • 제조사 주소
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • 제조사 모회사 (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA