Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation
Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to deviations in sodium conductivity and calcium concentration.
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 medical device used in hemodialysis with deviations in critical electrolyte concentrations (sodium and calcium). This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no specific injuries or illnesses are cited in the source text.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling Naturalyte Liquid Acid concentrate bottles (Product Code 08-2251-0). These products are used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in compatible 45X dilution three-stream artificial kidney (hemodialysis) machines.
The recall is due to a deviation in conductivity for sodium level that exceeds 0.6mS/cm from the theoretical conductivity or approximately 6mEq/L of sodium from prescriptions. Additionally, the calcium concentration in the affected units is below manufacturing specification.
The recall involves 3,083 cases distributed nationwide in the United States. Affected lot numbers include 20LXAC076, 20LXAC077, 20LXAC091, 20LXAC101, 20NXAC010, and additional lots identified as of March 17, 2021. Users should stop using the affected product and contact the manufacturer for instructions.
The recalled product
- Product
- Naturalyte Liquid Acid concentrate bottles, Product Code 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
- 3,083
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.
See all 11 products in this recall →Related recalls
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