PlainRecalls
FDA Devices Low Class III Terminated

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.

Reported: January 23, 2013 Initiated: November 26, 2012 #Z-0683-2013

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.

Reason for Recall

GranuFlo Dry Acid Concentrate may show discoloration

Details

Units Affected
670 units
Distribution
US Nationwide Distribution
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 670 units.
Why was this product recalled?
GranuFlo Dry Acid Concentrate may show discoloration
Which agency issued this recall?
This recall was issued by the FDA Devices on January 23, 2013. Severity: Low. Recall number: Z-0683-2013.