Fresenius Naturalyte Liquid Acid Concentrate Recalled for Conductivity Deviation
Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to conductivity deviations and calcium concentration below manufacturing specifications.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score (4) per the rubric, as it involves a product that could cause temporary or medically reversible health consequences.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 912 cases of Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0. The affected lots are 20LXAC088 and 20LXAC052. 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 (TCD), or approximately 6mEq/L of sodium from prescriptions. Additionally, the calcium concentration is below manufacturing specification.
The product is 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 product and contact the manufacturer for instructions.
The recalled product
- Product
- Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - 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
- 912
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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