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 involves a medical device used in hemodialysis where chemical levels are below specifications, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 1,006 cases of NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1. The affected products are identified by Lot Numbers 20LXAC090 and 20NXAC044. These products were distributed nationwide in the United States.
The recall was initiated because the sodium and/or calcium levels in these concentrates were below the manufacturing specifications. The product is used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Consumers and healthcare facilities should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - 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
- 1,006
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 Numbers: 20LXAC090 20NXAC044
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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