Events

Device Recall GranuFlo Dry Acid Concentrate 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
    63768
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0677-2013
  • 사례 시작날짜
    2012-11-26
  • 사례 출판 날짜
    2013-01-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-06-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114843
  • 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
    Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
  • 원인
    Granuflo dry acid concentrate may show discoloration.
  • 조치
    Fresenius Medical Care North America notified consignees by telephone on November 26, 2012 and follow-up letter on November 30, 2012 of the product recall. On January 10, 2013, the firm expanded there recall to an additional 32 lots (34 lots total). Customers were instructed to examine their inventory immediately, discontinue use, place all units in quarantine and return to Fresenius Medical Care North America. Customers were advised to contact their Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product. For questions contact the GranuFio Recall Line at 1-888-803-0509

Device

Device Recall GranuFlo Dry Acid Concentrate
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:12NXGF004, 12NXGF008, 12PXGF010, 12PXGF014
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL || Catalog Number: OFD2201-3B || Product Usage: || GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
  • 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