FDA-Device2013-01-23Class III
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.
Fresenius Medical Care Holdings, Inc.
Hazard
GranuFlo Dry Acid Concentrate may show discoloration
Sold states
US Nationwide Distribution
Affected count
14,240 units
Manufactured in
920 Winter St, N/A, Waltham, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0678-2013Don't want to check this manually?
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