Events

Device Recall Fresenius 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fresenius Medical Care Renal Therapies Group, 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
    73387
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1324-2016
  • 사례 시작날짜
    2016-02-26
  • 사례 출판 날짜
    2016-04-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-06-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144015
  • 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, capillary, hollow fiber - Product Code FJI
  • 원인
    Dialyzer header leak due to possible improper torque.
  • 조치
    The firm, Fresenius Medical Care Renal Therapies Group, LLC issued an "URGENT MEDICAL DEVICE RECALL" letter dated 2/24/16 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of your Hemoflow F3 Dialyzer; place all affected units in a secure, segregated area; contact your FMCRTG, LLC Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product, and fill out and return the attached Reply Form via fax to: 781-699-9796 ATTN: Quality Department or scan and email to: NOTIFYRA@fmc-na.com at your earliest convenience. If you have any additional medical concerns or questions, please contact Medical Information and Communication at 855-616-2309 or Website: www.fresenius-medinfo.com.

Device

Device Recall Fresenius
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 15KU04011 Exp. Date : 08/31/2013
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution including states of: AZ, CA, CT, DC, GA, IL, IN, MI, MN, MO, MS, NY, OH, PA, SC, SD, TX, and WA.
  • 제품 설명
    Fresenius Hemoflow F3 Dialyzer || Part Number: 0520165A || Indicated for Acute and Chronic Hemodialysis
  • Manufacturer
    Fresenius Medical Care Renal Therapies Group, LLC

Manufacturer

Fresenius Medical Care Renal Therapies Group, LLC
  • 제조사 주소
    Fresenius Medical Care Renal Therapies Group, LLC, 920 Winter St, Waltham MA 02451-1521
  • 제조사 모회사 (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA