Device Recall NaturaLyte Sodium Bicarbonate Liquid Concentrate

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 11 BMLB005 (Incorrect Lot Number: 11 BLMB005)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution--AL, CA, CT, FL, GA, NJ, NV, NY, OR, PA, and WA
  • 제품 설명
    Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid || Part number: 08-4000-LB || Formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • 제조사 모회사 (2017)
  • Source
    USFDA