Z-1827-2015Class II

NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle...

Name: Z-1827-2015 NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2015-05-20
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2015-05-20 / Open, Classified / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is... on 2015-05-20. FDA classified it as Class II and gives the reason as "Bacterial contamination". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1827-2015
Classification: Class II
Status: Open, Classified
Initiated: 2015-05-20
Posted: 2015-06-22
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: Bacterial contamination.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Fresenius Medical Care sent an Urgent Medical Device Recall letter dated May 15, 2015, to all affected customers. Users were requested to Immediately examine stock to determine whether they have any Naturalyte Liquid Bicarbonate Concentrate of the lots. " If any product of these lots is found, discontinue use immediately. " Place all units in a secure, segregated area. " If affected product was on the machine prior to patient treatment, perform a [Heat Disinfect] program. " Your dialysis schedule should not be interrupted. If interruption of your dialysis schedule is expected, please discuss your options with your health care provider. " Contact FMCNA Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product. " Promptly fill out and return the attached reply form Additional medical concerns or questions, please contact Medical Information and Communication: 855-616-2309 or Website: www.fresenius-medinfo.com. For questions regarding this recall call 800-662-1237.
Quantity in commerce: 1,856,619 Bottles
Distribution: Nationwide Distribution
Product codes and lots: Affected lots begin with: 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMBL, 14NMLB, 14PMLB, and 14SMLB.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1827-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1827-2015	Class II	Ongoing	Voluntary: Firm initiated	2015-07-01	2015-06-22

Product code KPO

K071387Class IIFresenius Naturalyte Sodium Bicarbonate Liquid Concentrate, Model 08-4000-LbFresenius Medical Care North America / cleared 2007-06-15

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)