Device Recall ExactaMix 2400(EM2400) Compounder Operating Ststem 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxa Corporation 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
    52024
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1389-2012
  • 사례 시작날짜
    2009-03-23
  • 사례 출판 날짜
    2012-04-09
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-04-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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/device, pharmacy compounding - Product Code NEP
  • 원인
    Software issue with compounding pump resulting in over delivery of component ingredients during routine operations.
  • 조치
    Baxa sent a Safety Alert letter dated March 23, 2009 to all affected consignees. The letter identified the affected product, problem and recommended actions with specific instructions related to the issue. Additionally, the firm will be providing a warning label for the affected product as soon as possible and is currently working on a product upgrade to correct the issue. For assistance contact Baxa Technical Support at 800-678-2292. The firm is also providing a 24 hour a day, 7 days a week Technical Support for the affected product.

Device

  • 모델명 / 제조번호(시리얼번호)
    2 model numbers 2400 D and 2400 M.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide including Canada.
  • 제품 설명
    Pharmacy compounding system . It is a twenty-four source compounder for multi-source fluid mixing of both macro and micro ingredient down to 0.2 ml quantities. || Product Usage: Pharmacy compounding System for parenteral macro and micro ingredients
  • Manufacturer

Manufacturer

  • 제조사 주소
    Baxa Corporation, 14445 Grasslands Dr, Englewood CO 80112
  • 제조사 모회사 (2017)
  • Source
    USFDA