FDA (Devices) recall action 63768

Fresenius Medical Care Holdings, Inc. recalled 9 products on 2013-01-23

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2013-01-23
Critical: 0
Units: 158,107

Why these products were recalled

GranuFlo Dry Acid Concentrate may show discoloration

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–9 of 9

LowFDA (Devices)··2013-01-23
Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration
Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis because the product may show discoloration.
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.
Category
Distribution
0 states
LowFDA (Devices)··2013-01-23
Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration
Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 670 units distributed nationwide.
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.
Category
Distribution
0 states
LowFDA (Devices)··2013-01-23
Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration
Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 14,240 units distributed nationwide.
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.
Category
Distribution
0 states
LowFDA (Devices)··2013-01-23
Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration
Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 2,711 units distributed nationwide.
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.
Category
Distribution
0 states
LowFDA (Devices)··2013-01-23
Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration
Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis because the product may show discoloration.
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.
Category
Distribution
0 states
LowFDA (Devices)··2013-01-23
Fresenius GranuFlo Dry Acid Concentrate Recalled for Potential Discoloration
Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis because the product may show discoloration.
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.
Category
Distribution
0 states
LowFDA (Devices)··2013-01-23
Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration
Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 5 units distributed nationwide.
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.
Category
Distribution
0 states
LowFDA (Devices)··2013-01-23
Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration
Fresenius Medical Care is recalling specific lots of GranuFlo Dry Acid Concentrate because the product may show discoloration.
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.
Category
Distribution
0 states
LowFDA (Devices)··2013-01-23
Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration
Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate due to potential discoloration. The product is used for hemodialysis treatment.
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.
Category
Distribution
0 states