Device Recall Hudson RCI AQUA Flex, Hygroscopic Condenser Humidifier

  • 모델명 / 제조번호(시리얼번호)
    Catalog number-- 1570, Lot numbers: 200910, 200911, 200913, 200914, 200916, 200919, 200920, 200921, 200927, 200928, 200929, 200930, 200940, 200941, 200942, 200943, 200945, 200948 and 200951.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution in the states of CA, FL, GA, KY, KS, IL, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, VA, and WI and to the country of Japan.
  • 제품 설명
    Hudson RCI¿ AQUA+¿ Flex, Hygroscopic Condenser Humidifier, HCH Tidal Volume Range 300-1500mL, ICU/Anesthesia Adult/Child, Catalog number 1570, Distributed by Teleflex Medical. The Aqua+ Flex is a passive humidifier indicated for use on patients under anesthesia and intensive care to effectively warm and humidify the inspired air.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • 제조사 모회사 (2017)
  • Source
    USFDA