Z-2110-2018Class II

NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1

Name: Z-2110-2018 NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1
Creator: Fresenius Medical Care Renal Therapies Group, LLC
Published: 2018-05-02
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2018-05-02 / Terminated / root cause: manufacturing process

FDA source

Fresenius Medical Care Renal Therapies Group, LLC began a recall of NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in... on 2018-05-02. FDA classified it as Class II and gives the reason as "The bottles are mislabeled with an incorrect part number". 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-2110-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-02
Posted: 2018-06-07
Terminated: 2020-05-13
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. For every 45 volume parts of dialysate: 1 volume part of the NaturaLyte acid concentrate, 1.72 volume parts of FMCNA Sodium Bicarbonate Concentrate and 42.28 volume parts of Purified Water (AAMI quality) are used.
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: The bottles are mislabeled with an incorrect part number.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Phone calls and Urgent Medical Device Recall notification letters were issued on 5/2/18. Customers were instructed to do the following: Immediately examine your stock to determine whether you have any NaturaLyte Liquid Acid from the lot listed above. If any products of this lot is found, discontinue use immediately. Place all units in a secure, segregated area. Contact your FMCRTG, LLC Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product and arrange for replacement product. Promptly fill out and return the attached reply form.
Quantity in commerce: 1060 cases (4240 bottles)
Distribution: Worldwide Distribution - US Nationwide in the states: CA, IA, IL, IN, KS, MD, MI, MN, MS, NE, NJ, NV, OK, PA, SD, TX, and WI.
Product codes and lots: Lot Code: 18CXAC095

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2110-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2110-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07

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)