Devices

Device Recall GranuFlo Dry Acid Concentrate

Model / Serial
Lot Numbers:12NXGF011, 12PXGF004
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution
Product Description
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL || Catalog Number: OFD2225-3B || 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
- Recall of Device Recall GranuFlo Dry Acid Concentrate

Manufacturer

Fresenius Medical Care Holdings, Inc.

Manufacturer Address
Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
Manufacturer Parent Company (2017)
Fresenius SE & Co KGaA
Source
USFDA

8 devices with a similar name

Learn more about the data here

Device Recall GranuFlo Dry Acid Concentrate

Model / Serial
Lot Numbers: 12NXGF001, 12NXGF003, 12NXGF006, 12NXGF007, 12NXGF013,, 12NXGF015, 12NXGF016, 12NXGF017, 12PXGF001, 12PXGF003, 12PXGF005, 12PXGF007, 12PXGF009, 12PXGF012, 12PXGF013, 12PXGF015, 12PXGF016
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution
Product Description
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.

Device Recall GranuFlo Dry Acid Concentrate

Model / Serial
Lot Numbers:12NXGF004, 12NXGF008, 12PXGF010, 12PXGF014
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution
Product Description
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

Model / Serial
Lot Number:12NXGF012
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution
Product Description
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

Model / Serial
Lot Number:12PXGF017
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution
Product Description
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

Model / Serial
Lot Number:12PXGF002
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution
Product Description
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.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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