Fresenius Recalls Naturalyte Liquid Bicarbonate Concentrate Due to Contamination
Fresenius Medical Care is recalling Naturalyte Liquid Bicarbonate Concentrate bottles due to potential contamination. The product is used in hemodialysis machines.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Naturalyte Liquid Bicarbonate maybe contaminated"
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle (Part Number: 08-4000-LB). The recall involves 672,784 units distributed nationwide in the United States and in Canada. The product is formulated for use with three steam hemodialysis machines calibrated for acid and bicarbonate concentrates.
The recall was initiated because the product may be contaminated. The source text does not specify the type of contaminant, the cause of the contamination, or any reported illnesses or injuries associated with the use of the product.
Healthcare facilities and consumers who have this product should stop using it and contact the manufacturer for further instructions. The recall covers specific lot numbers identified in the agency's record, including an initial set of 49 lots and an expanded set of 9 lots.
The recalled product
- Product
- Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle 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.
- Hazard
- Affected units
- 672,784
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 (20)
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Distribution
Distributed nationwide across the United States.
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