Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0824-2021·Announced 2021-01-20

Fresenius NaturaLyte Liquid Acid Concentrate Drums Recalled for Low Levels

Fresenius Medical Care is recalling 27 drums of NaturaLyte Liquid Acid concentrate 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a deviation from manufacturing specifications (low sodium/calcium) without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling 27 drums of NaturaLyte Liquid Acid concentrate, Model Number 13-2201-5. The affected lots are 20LXAC030, 20LXAC084, 20NXAC002, 20LXAC014, and 20NXAC018. These products were distributed nationwide in the United States.

The recall was initiated because the sodium and/or calcium levels in the concentrate were below manufacturing specifications. The product is used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Healthcare facilities and users should stop using the affected lots and contact the manufacturer for further instructions.

The recalled product

Product: NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - 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: mis-labeling
specification-deviation
Affected units: 27

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot Numbers: 20LXAC030 20LXAC084 20NXAC002 20LXAC014 20NXAC018

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 · mis labeling