Z-1827-2012Class I

Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B...

Name: Z-1827-2012 Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2012-03-29
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2012-03-29 / Terminated / root cause: labeling and UDI

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2225-3B, OFD2231-3B... on 2012-03-29. FDA classified it as Class I and gives the reason as "Risk of Alkalosis with acetate containing dialysis acid concentrates". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1827-2012
Classification: Class I
Status: Terminated
Initiated: 2012-03-29
Posted: 2012-06-25
Terminated: 2017-07-20
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2225-3B, OFD2231-3B, OFD2251-3B, OFD2301-3B, OFD2323-3B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B. For the treatment of acute and chronic renal failure during hemodialysis procedure.
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: Risk of Alkalosis with acetate containing dialysis acid concentrates
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Fresenius Medical Care sent an "IMPORTANT PRESCRIBING INFORMATION" letter dated March 29, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Reply Form was enclosed for customers to complete and return via fax to 781-699-9635. Contact Customer Service at 1-800-323-5188 or Medical Information at 1-855-616-2309 for questions regarding this recall.
Distribution: Nationwide Distribution and the country of Guam.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1827-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1826-2012	Class I	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-25
Z-1827-2012	Class I	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-25

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)