Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0814-2021·Announced 2021-01-20

Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a deviation from manufacturing specifications without reported adverse health consequences, fitting the criteria for a moderate severity score.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling 180 cases of NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2. The affected lot number is 20NXAC034. These products were distributed nationwide in the United States.

The recall was initiated because the sodium and/or calcium levels in these concentrates were below the 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.

Consumers and healthcare facilities should stop using the affected product and contact the manufacturer for further instructions.

The recalled product

Product: NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - 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: contamination
mis-labeling
Affected units: 180

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: 20NXAC034

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.

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