Z-2686-2014Class II

Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated...

Name: Z-2686-2014 Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2014-06-23
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2014-06-23 / Terminated / root cause: labeling and UDI

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine... on 2014-06-23. FDA classified it as Class II and gives the reason as "Product was held at temperature above the labeled recommended storage temperature". 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-2686-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-23
Posted: 2014-09-23
Terminated: 2021-01-29
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The 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: Product was held at temperature above the labeled recommended storage temperature
Root cause tag: labeling and UDI
FDA root cause: Storage
Action: Fresenius Medical North America contacted customers via telephone on 6/23/14 by Customer Service and follow-up with formal letter notification, Urgent Recall by certified mail with signature confirmation and faxback form Customers instructed to examine their inventory to determine whether they have any of the affected Naturalyte Liquid Bicarbonate. If customers have the affected product, they are instructed to contact FMC-RTG Customer Service to have the product replaced. A revised/clarification letter dated 7/10/14 issued to state only products from the identified lots that were delivered by RTG LLC to the specified facilities on May 5, 2014 are affected by this recall as products were exposed to temperatures higher than their recommended storage temperature during transportation on May 5, 2014. If you have any additional questions, please contact your FMCNA Customer Service Team at 1-800-323-5188.
Quantity in commerce: 72 cases
Distribution: Distributed in Texas.
Product codes and lots: Lot Number: 14BMLB012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2686-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2686-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-23

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)