Agency classClass IIOur severity:Severe FDA (Devices)·Z-0816-2021·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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a critical medical device component where chemical levels are below specifications, posing a risk of serious injury or death to hemodialysis patients.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3. The recall involves 8,272 cases distributed nationwide in the United States. The affected lot numbers are 20LXAC056, 20LXAC057, 20NXAC038, 20LXAC041, 20LXAC055, 20NXAC013, and 20NXAC035.

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

The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare facilities should stop using the affected products and contact the manufacturer for further instructions.

The recalled product

Product: NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - 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-concentration-defect
Affected units: 8,272

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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