Events

Fresenius LIBERTY Cycler Sets 05087216, Automated Peritoneal Dialysis System lntegrated Cycler Set 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
    56675
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0105-2011
  • 사례 시작날짜
    2010-09-03
  • 사례 출판 날짜
    2010-10-20
  • 사례 상황
    Completed
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94222
  • 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
    System, peritoneal, automatic delivery - Product Code FKX
  • 원인
    Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis.
  • 조치
    Fresenius Medical Care issued an Urgent FMCNA LIBERTY Cycler Set Recall letter on September 3, 2010 identifying the specific affected part numbers and product lots and requesting that customers identify and discontinue the use of the affected lots immediately. Customers were requested to return a receipt of notification. Customers may arrange return unused product to FMCNA by contacting customer service at 1-800-323-5188.

Device

Fresenius LIBERTY Cycler Sets 05087216, Automated Peritoneal Dialysis System lntegrated Cycler Set
  • 모델명 / 제조번호(시리얼번호)
    Lot Number Expiration Date 09ER08101 05/31/2012 09HR08002 06/30/2012 09HR08003 06/30/2012 09JR08057 07/31/2012 09JR08058 07/31/2012 09JR08059 07/31/2012 09KR08002 08/31/2012 09KR08003 08/31/2012 09KR08004 08/31/2012 09KR08005 08/31/2012 09LR08004 09/30/2012 09LR08005 09/30/2012 09LR08006 09/30/2012 09LR08007 09/30/2012 09LR08008 09/30/2012 09LR08010 09/30/2012 09LR08105 09/30/2012
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution: Throughout USA.
  • 제품 설명
    LIBERTY Automated Peritoneal Dialysis System lntegrated Cycler Set with single stay safe patient connector and extended drain line PIN: 050-87216. manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoza, Reynosa Tampa, Mexico.
  • 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