Z-0839-2021Class II

Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 -

Name: Z-0839-2021 Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 -
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2020-11-23
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2020-11-23 / Open, Classified / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate... on 2020-11-23. FDA classified it as Class II and gives the reason as "The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0839-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-11-23
Posted: 2021-01-11
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Recall notification letter dated 11/23/20 was sent to customers. Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) previously issued Urgent Medical Device Alerts on November 7, 2020 and November 14, 2020 alerting you to issues pertaining to the sodium level in the Naturalyte Liquid Acid concentrate and Citrasate Liquid Acid concentrate products impacting 105 lots, manufactured at the Oregon, Ohio facility between September 9, 2020 and October 29, 2020. After further testing, FMCRTG is now voluntarily recalling 28 of the 105 lots for one or both of the following reasons: " The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. " Calcium concentration is below manufacturing specification. The 28 lots were released for distribution between September 30, 2020 and November 20, 2020. Please check your stock and discontinue use and/or distribution of the products. If you have any listed lot numbers, place the product in a secure, segregated area. Please contact Stericycle at 1-866-912-9552 for instructions on how to return the product and receive credit This is EVENT# 5857. o If returning single bottles, please place affected product in a box for pick up. o In order to receive credit for your impacted product, you must call the Stericycle phone number above and provide quantities for return. Additional Information: If urgent replacement of product is needed, please call FMCRTG Customer Service at 1-800-323-5188. Otherwise, please add any additional product request to your next scheduled delivery. We apologize for any inconvenience. Please complete and return the enclosed Reply Form at your earliest convenience and contact our Customer Services team at 1-800-323-5188 with any additional questions. Please contact our Medical Information team at 1-855-616-2309 to discuss any medical or scie
Quantity in commerce: 224 drums
Distribution: US Nationwide distribution.
Product codes and lots: Lot Numbers: 20LXAC025 20LXAC081 20LXAC082 20LXAC083 Additional Affected lots as of 3/17/21: 20LXAC029 20NXAC021 20LXAC026 20LXAC065 20LXAC028 20NXAC029 20LXAC071 20LXAC103 20LXAC027 20LXAC070 20LXAC067 20NXAC019 20LXAC082 20LXAC025 20LXAC081 20LXAC083

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0839-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0831-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-20	2021-01-11
Z-0832-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-20	2021-01-11
Z-0833-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-20	2021-01-11
Z-0834-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-20	2021-01-11
Z-0835-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-20	2021-01-11
Z-0836-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-20	2021-01-11
Z-0837-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-20	2021-01-11
Z-0838-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-20	2021-01-11
Z-0839-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-20	2021-01-11
Z-0840-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-20	2021-01-11
Z-0841-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-20	2021-01-11

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)