Device Recall NaturaLyte Liquid Acid Concentrate

  • 모델명 / 제조번호(시리얼번호)
    Lot Code: 18CXAC095
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states: CA, IA, IL, IN, KS, MD, MI, MN, MS, NE, NJ, NV, OK, PA, SD, TX, and WI.
  • 제품 설명
    NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 || Product Usage: || This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. For every 45 volume parts of dialysate: 1 volume part of the NaturaLyte acid concentrate, 1.72 volume parts of FMCNA Sodium Bicarbonate Concentrate and 42.28 volume parts of Purified Water (AAMI quality) are used.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Fresenius Medical Care Renal Therapies Group, LLC, 920 Winter St, Waltham MA 02451-1521
  • 제조사 모회사 (2017)
  • Source
    USFDA