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.
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 and calcium). 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 2,246 cases of Naturalyte Liquid Acid concentrate bottles (Product Code 08-2201-5). The affected lots are 20LXAC086, 20LXAC099, 20NXAC014, 20LXAC061, and 20LXAC062. These products 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, which corresponds to approximately 6mEq/L of sodium from prescriptions. Additionally, the calcium concentration in the affected bottles is below manufacturing specification.
These concentrate bottles are used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. Users should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - 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
- 2,246
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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