Fresenius Naturalyte Liquid Acid concentrate drums recalled for conductivity deviation
Fresenius Medical Care is recalling 224 drums of Naturalyte Liquid Acid concentrate due to deviations in conductivity and calcium concentration.
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 with deviations in chemical specifications (sodium conductivity and calcium concentration). Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 224 drums of Naturalyte Liquid Acid concentrate, Product Code 13-2251-0. 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 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 affected lots are 20LXAC025, 20LXAC081, 20LXAC082, 20LXAC083, 20LXAC029, 20NXAC021, 20LXAC026, 20LXAC065, 20LXAC028, 20NXAC029, 20LXAC071, 20LXAC103, 20LXAC027, 20LXAC070, 20LXAC067, and 20NXAC019. The product was distributed nationwide in the United States.
The recalled product
- Product
- Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - 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
- 224
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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