Fresenius Naturalyte Liquid Acid Concentrate Recall for Conductivity Deviation
Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to conductivity deviations and low calcium levels.
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 involves a high-risk medical device used in hemodialysis with manufacturing deviations affecting electrolyte levels, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3. The product is used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in compatible 45X dilution three-stream artificial kidney (hemodialysis) machines.
The recall was initiated because the deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD), or approximately 6mEq/L of sodium from prescriptions. Additionally, the calcium concentration is below manufacturing specification.
The recall affects 1,426 cases distributed nationwide in the United States. Affected lot numbers include 20NXAC013, 20NXAC035, 20LXAC056, 20LXAC041, 20LXAC055, and 20LXAC057.
The recalled product
- Product
- Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - 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
- 1,426
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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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