Z-1311-2022Class II

NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3

Name: Z-1311-2022 NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2022-06-01
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2022-06-01 / Terminated / root cause: packaging

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3 on 2022-06-01. FDA classified it as Class II and gives the reason as "The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1311-2022
Classification: Class II
Status: Terminated
Initiated: 2022-06-01
Posted: 2022-07-01
Terminated: 2024-10-07
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On June 1, 2022, the firm reached out to its affected customers via telephone to explain the product issue. Customers were instructed to identify and segregate the affected product immediately and remove the product from inventory. If customers had any product to return, the recalling firm would have a customer service representative follow up with the customer. Customers were reminded to always inspect packaging for leaks.
Quantity in commerce: 3 cases
Distribution: US Nationwide distribution in the states of Texas and Louisiana.
Product codes and lots: UDI: (01)00840861101702 (17) 230131 (10) 21AGAC009 Lot 21AGAC009

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1311-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1311-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-13	2022-07-01

Product code KPO

K192017Class IICitrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC / cleared 2020-04-24

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)