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.
Reported: January 20, 2021 Initiated: November 23, 2020 #Z-0834-2021
Product Description
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.
Reason for Recall
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 278 cases
- Distribution
- US Nationwide distribution.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 278 cases.
Why was this product recalled? ▼
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 20, 2021. Severity: Moderate. Recall number: Z-0834-2021.
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