Fresenius Naturalyte Liquid Bicarbonate Concentrate Recalled for Temperature Violation
Fresenius Medical Care is recalling 72 cases of Naturalyte Liquid Bicarbonate Concentrate distributed in Texas because the product was held at temperatures above the recommended storage range.
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 illnesses, injuries, or hospitalizations. The hazard is a storage temperature deviation, which fits the criteria for a moderate, precautionary recall without reported harm.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 72 cases of Fresenius Naturalyte Liquid Bicarbonate Concentrate, Product Number 08-4000-LB, Lot Number 14BMLB012. The product was distributed in Texas. This concentrate is formulated for use with three steam hemodialysis machines calibrated for acid and bicarbonate concentrates.
The recall was initiated because the product was held at a temperature above the labeled recommended storage temperature. This deviation from storage requirements may affect the product's stability or safety.
Patients and healthcare facilities in Texas who have this specific lot of the product should stop using it and contact their supplier or Fresenius Medical Care for further instructions.
The recalled product
- Product
- Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 72
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 Number: 14BMLB012
Distribution
Distributed in 1 state:
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