Devices

Device Recall GranuFlo Dry Acid Concentrate

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 12NXGF001, 12NXGF003, 12NXGF006, 12NXGF007, 12NXGF013,, 12NXGF015, 12NXGF016, 12NXGF017, 12PXGF001, 12PXGF003, 12PXGF005, 12PXGF007, 12PXGF009, 12PXGF012, 12PXGF013, 12PXGF015, 12PXGF016
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL || Catalog Number: OFD2251-3B || Product Usage: || GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.
  • 1 Event

제조사

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

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Device Recall GranuFlo Dry Acid Concentrate
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:12NXGF004, 12NXGF008, 12PXGF010, 12PXGF014
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL || Catalog Number: OFD2201-3B || Product Usage: || GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.
Device Recall GranuFlo Dry Acid Concentrate
  • 모델명 / 제조번호(시리얼번호)
    Lot Number:12NXGF012
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL || Catalog Number: OFD2223-3B || Product Usage: || GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.
Device Recall GranuFlo Dry Acid Concentrate
  • 모델명 / 제조번호(시리얼번호)
    Lot Number:12PXGF017
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL || Catalog Number: OFD3201-3B || Product Usage: || GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.
Device Recall GranuFlo Dry Acid Concentrate
  • 모델명 / 제조번호(시리얼번호)
    Lot Number:12PXGF002
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL || Catalog Number: OFD2325-3B || Product Usage: || GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.
Device Recall GranuFlo Dry Acid Concentrate
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:12NXGF002, 12NXGF014, 12PXGF006,
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL || Catalog Number: OFD3251-3B || Product Usage: || GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.
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