Fresenius NaturaLyte Liquid Bicarbonate Concentrate Recalled for Manganese Contamination
Fresenius Medical Care is recalling NaturaLyte Liquid Bicarbonate Concentrate bottles because the container caps may contain foreign material with elevated manganese levels.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which is defined as unlikely to cause adverse health consequences. The hazard involves potential foreign material (manganese) in the cap, but no illnesses or injuries are reported in the source text.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 12 bottles of NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottles, Part Number 08-4000-LB. The product is formulated for use with three steam hemodialysis machines calibrated for acid and bicarbonate concentrates.
The recall was initiated because the container caps may contain foreign material consisting of 0.60% to 0.80% Manganese. The affected lot number is 14CMLB006. The product was distributed in the state of Missouri.
The source text does not specify specific actions for consumers or patients, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part 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.
- Affected units
- 12
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: 14CMLB006
Distribution
Distributed in 1 state:
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