Device Recall enFlow Disposable IV Fluid/Blood Warmer Cartridge

  • 모델명 / 제조번호(시리얼번호)
    Model numbers: 9800200, 9800202, 9800200EU, 9800202EU, 9100020010, 9100020210, 91000153, 91000154, 91000156. Master lot numbers on shipping cartons: oo1K through 365K, 001P through 365P, 001S through 365S.  Shelf carton and unit level lot numbers" 0901xxxx through 1001xxxx
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution; USA (all states), and to the countries of Australia, Ecuador, Finland, India, Israel, Latvia, Lebanon, Malaysia, Mexico, Morocco, New Zealand, Panama, Philippines, Qatar, Saudi Arabia, Singapore, Switzerland, the Netherlands, and Vietnam.
  • 제품 설명
    Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to warm blood and IV fluids.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Vital Signs Inc, 20 Campus Rd, Totowa NJ 07512
  • 제조사 모회사 (2017)
  • Source
    USFDA