—#114843

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.

FDA product code: KPO — Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K030497
Affected lot / code info: Lot Numbers:12NXGF004, 12NXGF008, 12PXGF010, 12PXGF014

Why it was recalled

GranuFlo Dry Acid Concentrate may show discoloration

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2012-11-26
Posted by FDA: 2013-01-17
Terminated: 2016-06-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114843. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.