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 were below specifications, representing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 527 cases of NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4, Lot Number 20LXAC042. The product was 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.
Patients and healthcare facilities using this product should stop using the affected lot and contact their supplier or the manufacturer for further instructions.
The recalled product
- Product
- NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - 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
- 527
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: 20LXAC042
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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