Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation
Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to conductivity deviations and calcium concentration below specification.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the product is a medical device used in hemodialysis where deviations in electrolyte levels (sodium and calcium) pose a significant risk of harm to patients.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1. 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 is due to a deviation in conductivity for sodium level that 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 20LXAC063, 20NXAC008, 20NXAC005, 20LXAC098, and 20NXAC039. A total of 1,686 cases were distributed nationwide in the United States. Consumers and healthcare facilities should stop using the affected product and contact the manufacturer for instructions.
The recalled product
- Product
- Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - 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.
- Category
- Medical Device — Dialysis
- Affected units
- 1,686
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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