Z-0181-2023Class II

NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For...

Name: Z-0181-2023 NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2022-10-04
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2022-10-04 / Open, Classified / root cause: labeling and UDI

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis on 2022-10-04. FDA classified it as Class II and gives the reason as "The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0181-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-04
Posted: 2022-11-04
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On October 4, 2022, the firm notified affected customers via Important Medical Device Information letters. Customers were reassured that the product was manufactured according to specification and remains potassium-free. Customers may continue to use the product. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have further questions.
Quantity in commerce: 17700
Distribution: Domestic distribution to AL AZ CA DC FL GA HI IL IN MD MI MO MS NE NJ NY OH PA SD TX VA No foreign distribution.
Product codes and lots: UDI-DI: 00840861101610 Lots: 20LTAC076 20PTAC094 21ATAC046 21BTAC082 21CTAC029 21KTAC072 21PTAC023 21STAC094 22DTAC036

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0181-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0181-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-16	2022-11-04

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)