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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Device

Fresenius Medical Care Holdings, Inc.: GranuFlo Dry Acid Concentrate may show discoloration

Agency Publication Date: January 17, 2013
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Affected Products

Product: 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.

Lot Numbers: 12NXGF001, 12NXGF003, 12NXGF006, 12NXGF007, 12NXGF013,, 12NXGF015, 12NXGF016, 12NXGF017, 12PXGF001, 12PXGF003, 12PXGF005, 12PXGF007, 12PXGF009, 12PXGF012, 12PXGF013, 12PXGF015, 12PXGF016

Lot Numbers:
Numbers
Product: 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.

Lot Numbers:12NXGF004, 12NXGF008, 12PXGF010, 12PXGF014

Lot Numbers:
Numbers
Product: 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.

Lot Numbers:12NXGF002, 12NXGF014, 12PXGF006,

Lot Numbers:
Numbers
Product: Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

Lot Numbers:12NXGF005, 12NXGF019, 12PXGF008

Lot Numbers:
Numbers
Product: Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD1201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

Lot Number:12NXGF009

Lot Numbers:
Number
Product: 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.

Lot Numbers:12NXGF011, 12PXGF004

Lot Numbers:
Numbers
Product: 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.

Lot Number:12NXGF012

Lot Numbers:
Number
Product: 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.

Lot Number:12PXGF017

Lot Numbers:
Number
Product: 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.

Lot Number:12PXGF002

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 63768
Status: Resolved
Manufacturer: Fresenius Medical Care Holdings, Inc.
Manufactured In: United States
Units Affected: 9 products (101,108 units; 17,782 units; 14,240 units; 13,409 units; 5 units; 5,689 units; 2493 units; 670 units; 2711 units)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.