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. The hazard involves a deviation from manufacturing specifications for a medical device used in hemodialysis, which poses a risk of harm, but the source text does not report specific injuries or illnesses.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9. The recall involves 19,646 cases of the product, which was distributed nationwide in the United States. The product is used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The recall was initiated because the sodium and/or calcium levels in these concentrates were below the manufacturing specifications. Specific lot numbers affected include 20LXAC043, 20LXAC044, 20LXAC045, 20LXAC059, 20LXAC060, 20LXAC079, 20LXAC095, 20NXAC026, 20LXAC078, 20NXAC012, 20LXAC058, 20LXAC096, and 20NXAC011.
Healthcare facilities and consumers should check their inventory for the affected model number and lot numbers. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to the recall instructions.
The recalled product
- Product
- NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - 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
- 19,646
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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