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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 3 Recall
GranuFlo Dry Acid Concentrate		see related information
Date Posted January 17, 2013
Recall Number Z-0677-2013
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.
Code Information Lot Numbers:12NXGF004, 12NXGF008, 12PXGF010, 12PXGF014
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham, Massachusetts 02451-1521
Reason for
Recall		 GranuFlo Dry Acid Concentrate may show discoloration
Action Fresenius Medical Care North America notified consignees by telephone on November 26, 2012 and follow-up letter on November 30, 2012 of the product recall. On January 10, 2013, the firm expanded there recall to an additional 32 lots (34 lots total). Customers were instructed to examine their inventory immediately, discontinue use, place all units in quarantine and return to Fresenius Medical Care North America. Customers were advised to contact their Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product. For questions contact the GranuFio Recall Line at 1-888-803-0509.
Quantity in Commerce 17,782 units
Distribution US Nationwide Distribution
 
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