Device Recall ExactaMix

제조사

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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 8 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    ExactaMix 1200 serial numbers 45004-45481 (sequentially), and ExactaMix 2400 serial numbers 40005-40335.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.
  • 제품 설명
    ExactaMix 1200 and 2400 Compounders. || Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide
  • 제품 설명
    EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a single patient IV administration bag.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Version 1.07 of the EM2400 Operating Software. (Serial Numbers: 36805,36806,36356,36399,36804,36799,36797,36398,32438,36798,36460,36794,32346,36800,36801,36802,36803,(37767-36773), (36788-36793),36795 and 36796 (foreign)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Class I Recall-Worldwide Distribution: USA including states of CA, CO, FL, KY, MI, NY, OH, OR, and TX and the UK
  • 제품 설명
    Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112.
  • Manufacturer
  • 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
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 738391, 738392.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution, including USA, Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Japan, Malaysia, Mexico, New Zealand, Panama, Peru, Singapore, South Korea, Taiwan, and Uruguay.
  • 제품 설명
    Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation.
  • Manufacturer
하나 더 3 건 더