Fresenius Naturalyte Liquid Acid Concentrate Recall for Conductivity Deviation
Fresenius Medical Care is recalling 123 bottles of Naturalyte Liquid Acid concentrate 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 a deviation from manufacturing specifications, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 123 bottles of Naturalyte Liquid Acid concentrate, Product Code 08-2351-8. 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 covers lots 20NXAC033 and 20LXAC097, which were distributed nationwide in the United States.
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 in the affected product is below manufacturing specification.
Patients and healthcare facilities using this product should stop using the affected lots and contact Fresenius Medical Care for further instructions.
The recalled product
- Product
- Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - 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
- 123
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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