Z-1612-2012

Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x , 55 gallons (208.2 Liters) Cat...

Name: Z-1612-2012 Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x , 55 gallons (208.2 Liters) Cat...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2012-03-16
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2012-03-16 / Terminated / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x , 55 gallons (208.2 Liters) Cat. No. 13-2251-0. NaturaLyte liquid acid concentrate... on 2012-03-16. The reason FDA records is "Sodium content does not meet product requirements". 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-1612-2012
Status: Terminated
Initiated: 2012-03-16
Posted: 2012-05-15
Terminated: 2014-01-28
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x , 55 gallons (208.2 Liters) Cat. No. 13-2251-0. NaturaLyte liquid acid concentrate is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: Sodium content does not meet product requirements
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Fresenius Medical Care North America sent an "URGENT PRODUCT RECALL" letter dated March 28, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to examine their stock immediately to determine whether they have any affected product. A fax back form was included for customers to complete and return. Contact FMCNA Customer Service Team at 1-800-323-5188 for questions regarding this notice.
Quantity in commerce: 154 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot 11PTAC022. Expiration Date: 11/30/2013

Product code KPO

K981043Class IIDialysol-Acid Concentrate Liquid, Granusol-Acid Concentrate Powder, Renalsol-Acetate Concentrate Liquid & Powder, BiosolSolution Technologies / cleared 1998-05-26

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)