Z-0677-2013Class III

Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog...

Name: Z-0677-2013 Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2012-11-26
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2012-11-26 / Terminated / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of 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... on 2012-11-26. FDA classified it as Class III and gives the reason as "GranuFlo Dry Acid Concentrate may show discoloration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0677-2013
Classification: Class III
Status: Terminated
Initiated: 2012-11-26
Posted: 2013-01-17
Terminated: 2016-06-21
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
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.
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: GranuFlo Dry Acid Concentrate may show discoloration
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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
Product codes and lots: Lot Numbers:12NXGF004, 12NXGF008, 12PXGF010, 12PXGF014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0677-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0676-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-16
Z-0677-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-16
Z-0678-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-16
Z-0679-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-16
Z-0680-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-16
Z-0681-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-16
Z-0682-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-16
Z-0683-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-16
Z-0684-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-16

Product code KPO

K030497Class IIFresenius Naturalyte Granuflo Dry Acid Concentrate 10Xx Series, 24Xx Series, 30Xx SeriesFresenius Medical Care / cleared 2003-05-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)