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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 risk-of-harm product (hemodialysis concentrate) where specific injury or illness reports are not stated in the source text, fitting the criteria for a High severity score.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0. The recall involves 11,709 cases of the product that 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.
Affected lot numbers include 20LXAC048, 20LXAC053, 20LXAC047, 20NXAC016, 20LXAC094, 20NXAC009, 20LXAC049, 20LXAC054, 20NXAC025, and 20NXAC024. Additional affected lots identified as of March 17, 2021, include 20LXAC076, 20LXAC077, 20LXAC091, 20LXAC101, 20NXAC010, and 20NXAC016. Users should check their inventory for these specific lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - 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
- 11,709
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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