Fresenius Citrasate Liquid Acid Concentrate Recalled for Conductivity Deviation
Fresenius Medical Care is recalling Citrasate Liquid Acid concentrate bottles due to conductivity deviations and low calcium levels.
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 with a deviation in sodium conductivity and calcium concentration, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 278 cases of Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA. The affected lot number is 20NXAC007. The product was 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 is below manufacturing specification.
This 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 further instructions.
The recalled product
- Product
- Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-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.
- Category
- Medical Device — Dialysis
- Affected units
- 278
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 20NXAC007 Additional Affected lots as of 3/17/21: 20NXAC007
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.
See all 11 products in this recall →Related recalls
Same manufacturer · Fresenius Medical Care Holdings, Inc.
See all →- Moderate5008X Blood Tubing Set connection errors FDA Class II recall
FDA (Devices) · 2026-07-15
- HighBicarby dialysate bags carry an incorrect GTIN on the label
FDA (Devices) · 2026-06-17
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- SevereDELFLEX Peritoneal Dialysis Solution Recall Due to Potential Sterility Issues
FDA (Drugs) · 2026-05-13
- HighDELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
FDA (Drugs) · 2026-05-13
Same hazard · chemical deviation
See all →- HighFresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation
FDA (Devices) · 2021-01-20
- HighFresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation
FDA (Devices) · 2021-01-20
- HighFresenius Naturalyte Liquid Acid concentrate drums recalled for conductivity deviation
FDA (Devices) · 2021-01-20
- HighFresenius Citrasate Liquid Acid concentrate drums recalled for conductivity deviation
FDA (Devices) · 2021-01-20
- HighFresenius Naturalyte Liquid Acid concentrate drums recalled for conductivity deviation
FDA (Devices) · 2021-01-20