Z-1739-2014Class III

NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number...

Name: Z-1739-2014 NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2014-05-01
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2014-05-01 / Terminated / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be... on 2014-05-01. FDA classified it as Class III and gives the reason as "Container cap may contain foreign material- 0.60% - 0.80% Manganese". 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-1739-2014
Classification: Class III
Status: Terminated
Initiated: 2014-05-01
Posted: 2014-06-09
Terminated: 2016-06-15
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part 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: Container cap may contain foreign material- 0.60% - 0.80% Manganese
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Fresenius Medical notified customer by letter dated 5/1/14 to examine stock immediately and instructed to discontinue use and place all Naturalyte Liquid Bicarbonate Concentrate in a secure area for return to FMC-RTG. The customer instructed to contact the Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product.
Quantity in commerce: 12 bottles
Distribution: Distributed in the state of MO.
Product codes and lots: Lot Number: 14CMLB006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1739-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1739-2014	Class III	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-09

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)