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U.S. Department of Health and Human Services

Enforcement Report - Week of January 23, 2013
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Event Detail

Event ID 63768
Product Type Devices
Status Ongoing
Recalling Firm Fresenius Medical Care Holdings, Inc.
City Waltham
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-26
Initial Firm Notification of
Consignee or Public		 Letter
Distribution Pattern US Nationwide Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Class III GranuFlo Dry Acid Concentrate may show discoloration 101,108 units Z-0676-2013
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 Class III GranuFlo Dry Acid Concentrate may show discoloration 17,782 units Z-0677-2013
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, Class III GranuFlo Dry Acid Concentrate may show discoloration 14,240 units Z-0678-2013
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 Class III GranuFlo Dry Acid Concentrate may show discoloration 13,409 units Z-0679-2013
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 Class III GranuFlo Dry Acid Concentrate may show discoloration 5 units Z-0680-2013
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 Class III GranuFlo Dry Acid Concentrate may show discoloration 5,689 units Z-0681-2013
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 Class III GranuFlo Dry Acid Concentrate may show discoloration 2493 units Z-0682-2013
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 Class III GranuFlo Dry Acid Concentrate may show discoloration 670 units Z-0683-2013
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 Class III GranuFlo Dry Acid Concentrate may show discoloration 2711 units Z-0684-2013
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