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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device used in hemodialysis where chemical levels are below specifications, posing a risk of harm without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1. The recall involves 3,665 cases distributed nationwide in the United States. The affected lot numbers are 20NXAC005, 20LXAC098, 20NXAC037, 20NXAC039, 20NXAC008, and 20LXAC063.
The recall was initiated because the sodium and/or calcium levels in these concentrates were below the manufacturing specifications. This product is 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. No specific instructions for consumers or healthcare providers are provided in the source text beyond the identification of the affected product and lots.
The recalled product
- Product
- NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - 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.
- Affected units
- 3,665
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.
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