Events

Fresenius 132 Gallon GranuFlo Dissolution Unit 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
    72484
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0294-2016
  • 사례 시작날짜
    2015-10-23
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141212
  • 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
    Dissolution units and replacement motors units do not provide full thermal protection for both the main and starter coils resulting in the generation of smoke and/or potentially lead to fire.
  • 조치
    Fresenius issued an Urgent - Medical Device Correction notification, dated October 21, 2015, on 10/27/15. The letter identified the affected device and the reason for the recall. It also contained instructions (on how to perform the required wiring modification) along with a Reply Form. Customers are to return the form after completing the modification. Inquiries regarding the correction should be directed to Fresenius Technical Services at 800-227-2572, referencing the Field Action number FA-2015-01-W.

Device

Fresenius 132 Gallon GranuFlo Dissolution Unit
  • 모델명 / 제조번호(시리얼번호)
    All 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. || For Use in the Preparation of acid concentrate for 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