Fresenius Medical Care Recalls NaturaLyte Liquid Acid Concentrate Due to Missing Labels
Fresenius Medical Care is recalling 2,280 cases of NaturaLyte Liquid Acid concentrate because bottles are missing product labels.
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 explicitly states the issue is missing labels and does not report any illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 2,280 cases (9,120 bottles) of NaturaLyte Liquid Acid concentrate, Part Number 08-3251-9. The recall is due to bottles missing product labels. The affected lot code is 20NTAC040, and the product was distributed nationwide.
This product is a liquid acid concentrate used for bicarbonate hemodialysis. The recall is classified as Class II by the FDA. The source text does not report any illnesses or injuries associated with this recall.
Consumers and healthcare facilities should stop using the affected product and contact Fresenius Medical Care for instructions on how to return or dispose of the product.
The recalled product
- Product
- Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
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 code: 20NTAC040
Distribution
Distributed nationwide across the United States.
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