Fresenius Citrasate Liquid Acid concentrate drums recalled for conductivity deviation
Fresenius Medical Care is recalling two drums of Citrasate Liquid Acid concentrate 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) that could impact patient safety, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling two drums of Citrasate Liquid Acid concentrate, Product Code 13-2251 -CA. 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 20LXAC033, 20NXAC004, 20LXAC031, 20NXAC004, 20LXAC033, 20NXAC003, and 20LXAC032. The product was distributed nationwide in the United States. Users should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - 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
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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