Z-1010-2018Class II

NaturaLyte Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is...

Name: Z-1010-2018 NaturaLyte Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is...
Creator: Fresenius Medical Care Renal Therapies Group, LLC
Published: 2017-09-29
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2017-09-29 / Terminated / root cause: labeling and UDI

FDA source

Fresenius Medical Care Renal Therapies Group, LLC began a recall of NaturaLyte Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal... on 2017-09-29. FDA classified it as Class II and gives the reason as "The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L". 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-1010-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-29
Posted: 2018-03-14
Terminated: 2018-08-09
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: NaturaLyte Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle 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.
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.
Root cause tag: labeling and UDI
FDA root cause: Release of Material/Component prior to receiving test results
Action: The firm, Fresenius Medical Care, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated 10/4/2017 to its Consignees. The letter described the product, problem and actions to be taken. The Consignees are instructed to: " Immediately examine your stock to determine whether you have any Naturalyte Liquid Acid Concentrate from the lot listed. " If any product 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. " Promptly fill out and return the attached Reply Form via fax to: 781-699-9796 ATTN: Quality Department or SCAN and email to: [email protected].' and "Route the letter to others in your organization that may have any of the affected product that is subject to this recall. Please note that the Naturalyte Liquid Acid Concentrate matching the Lot Number listed in the notification is the only lot subject to this recall. If you have any additional medical concerns or questions, please contact Medical Information and Communication: 855-616-2309 or Website: www.fresenius-medinfo.com.
Quantity in commerce: 598 cases
Distribution: US Distribution to states of: CA, FL, KS, LA, and TX.
Product codes and lots: Lot # 17KTAC076; UDI-00840861101696

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1010-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1010-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14

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)