Agency classClass IIOur severity:High FDA (Devices)·Z-0825-2021·Announced 2021-01-20

Fresenius NaturaLyte Liquid Acid concentrate drums recalled for low sodium levels

Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate drums because sodium and/or calcium levels were below manufacturing specifications.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that could affect patient safety (low sodium/calcium levels), but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling 592 drums of NaturaLyte Liquid Acid concentrate, Model Number 13-2251-0. The product is used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The recall was initiated because the sodium and/or calcium levels in these concentrates were below the manufacturing specifications. The affected lots include 20LXAC070, 20LXAC103, 20NXAC021, 20LXAC100, 20LXAC026, 20LXAC027, 20LXAC028, 20LXAC029, 20LXAC065, 20LXAC067, 20LXAC071, 20NXAC001, 20NXAC019, 20NXAC020, 20NXAC029, 20LXAC082, 20LXAC025, 20LXAC081, and 20LXAC083.

The product was distributed nationwide in the United States. Healthcare facilities and consumers should stop using the affected product and contact Fresenius Medical Care for further instructions.

The recalled product

Product: NaturaLyte Liquid Acid concentrate drums, Model Number 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.
Manufacturer: Fresenius Medical Care Holdings, Inc.
Category: Medical Device — Dialysis Supplies
Hazard: chemical-deficiency
medical-device-defect
Affected units: 592

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 19 products in this recall →

Same manufacturer · Fresenius Medical Care Holdings, Inc.

See all →

Moderate
5008X Blood Tubing Set connection errors FDA Class II recall
FDA (Devices) · 2026-07-15
High
Bicarby dialysate bags carry an incorrect GTIN on the label
FDA (Devices) · 2026-06-17
High
Bicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
Severe
DELFLEX Peritoneal Dialysis Solution Recall Due to Potential Sterility Issues
FDA (Drugs) · 2026-05-13
High
DELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
FDA (Drugs) · 2026-05-13

Same hazard · chemical deficiency