Z-0942-2021Class II

Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis...

Name: Z-0942-2021 Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2020-12-17
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2020-12-17 / Terminated / root cause: packaging

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9 on 2020-12-17. FDA classified it as Class II and gives the reason as "Bottles Missing Product Label". 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-0942-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-17
Posted: 2021-02-01
Terminated: 2023-01-05
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: Bottles Missing Product Label
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Fresenius Medical Care (FMCRTG isssued URGENT MEDICAL DEVICE RECALL on 12/17/20 ia First Class Mail, letter states reason for recall, health risk and action to take: RETURN ONLY BOTTLES WITH NO LABEL OPEN AND CHECK ALL BOTTLES IN CASES of Lot Number 20NTAC040. " If you find any bottles from this lot with no labels, place the product in a secure, segregated area. Please contact FMCRTG Customer Service at 1-800-323-5188 for instructions on how to return the product and receive credit. o If returning single bottles, please place affected product in a box for pick up. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have unique circumstances or an urgent need concerning product delivery.
Quantity in commerce: 2,280 cases (9,120 bottles)
Distribution: Nationwide
Product codes and lots: Lot code: 20NTAC040

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0942-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0942-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-10	2021-02-01

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)