Z-0887-2016Class II

Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3

Name: Z-0887-2016 Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3
Creator: Fresenius Medical Care Renal Therapies Group, LLC
Published: 2016-01-18
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2016-01-18 / Terminated / root cause: labeling and UDI

FDA source

Fresenius Medical Care Renal Therapies Group, LLC began a recall of Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis on 2016-01-18. FDA classified it as Class II and gives the reason as "On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the...". 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-0887-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-18
Posted: 2016-02-25
Terminated: 2017-08-14
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm, Fresenius Medical Care, issued an "URGENT-MEDICAL DEVICE RECALL" letter dated 1/14/2015 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your stock for the product; if found, discontinue use immediately; place all units in a secure, segregated area; contact your FMCNA Customer Service Team at 1-800-323-5188 for instructions how to return the affected lot (lot# 15STAC072), and promptly complete and return the attached reply form by Fax to: 781-699-9796 Attn: Quality Department or scan and email to: [email protected]. Fresenius will pick up and replace your product. If you have any additional medical concerns or questions, please contact Medical Information and Communication at 855-816-2309 or Website: www.fresenius-medinfo.com. Further information or support concerning this issue, contact the Customer Service Care Team at 800-323-5188 and reference the and Support Field Action Number.
Quantity in commerce: 848 (212 cases)
Distribution: US Distribution to states of: KS, LA, MS, OK, and TX.
Product codes and lots: Lot Number: 15STAC072 Exp Date: 2017-12-31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0887-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0887-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25

Product code KPO

K070177Class IIFresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 and 4000 SeriesFresenius Medical Care North America / cleared 2007-03-29

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)