CitrasateRecalls & reported problems across all models

We found 4 models of Citrasate by Fresenius Medical Care Renal Therapies Group, LLC in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Nov 25, 2020 and Apr 5, 2021 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (24 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Citrasate recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 14, 2026Open, Classified

   Complaints of blue-green discoloration in product

   Z-3093-2026 · Root cause: Material/Component Contamination · names 3 of these models · Recall details · FDA record ↗

Most reported Citrasate problems

Citrasate models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Citrasate 08-3251-CA

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  1 recall21 reports
• Citrasate 08-2251-CA

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  1 recall1 report
• Citrasate 13-2251-CA

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  1 recall1 report
• Citrasate 13-3251-CA

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  1 report

Recent Citrasate adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2021Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A BATCH OF CITRASATE ACID CONCENTRATE WAS NOT ACHIEVING THE DESIRED CONDUCTIVITY. UPON FOLLOW UP, THE BMT INDICATED THEY WERE NOT SURE IF THE LOW CONDUCTIVITY WAS OBSERVED DURING SETUP OR TREATMENT. HE CONFIRMED THE UNSPECIFIED HEMODIALYSIS (HD) MACHINE ALARMED APPROPRIATELY. THE BMT DOES NOT RECALL THE EXACT CONDUCTIVITY LEVELS THAT WERE OBSERVED. IT WAS INDICATED THERE WAS NO ADVERSE EVENT, SERIOUS INJURY, NOR REQUIRED MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE REMAINING JUGS OF THE REPORTED LOT WERE SEQUESTERED AND FRESENIUS CUSTOMER SERVICE SCHEDULED TO RETURN THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617045 ↗
• MalfunctionFeb 3, 2021Chemical Problem; Chemical Problem

  A REGISTERED NURSE RN REPORTED THAT A 2008T MACHINE SHOWED LOW CONDUCTIVITY LEVELS WHEN USING A 3K CITRASATE ACID CONCENTRATE DURING HEMODIALYSIS (HD) TREATMENT. THE CONDUCTIVITY VALUES OBSERVED DURING TREATMENT WERE NOT REPORTED. IT WAS CONFIRMED THERE WAS NO ADVERSE EVENT, SERIOUS INJURY, NOR MEDICAL INTERVENTION REQUIRED DUE TO THIS EVENT. IT WAS REPORTED THAT OTHER MACHINES THAT USED JUGS FROM THE SAME BOX DID NOT EXPERIENCE THE REPORTED CONDUCTIVITY ISSUE. HE INDICATED THAT THE MACHINE INVOLVED IN THE EVENT HAD LOW CONDUCTIVITY RESULTS WITH JUGS FROM DIFFERENT BOXES. THE RN INDICATED HE SUSPECTS THE CAUSE OF THE REPORTED ISSUES IS THE MACHINE AND NOT THE PRODUCTS. MULTIPLE ATTEMPTS WERE MADE TO REACH THE BMT, BUT NOT RESPONSE WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11276612 ↗
• MalfunctionFeb 3, 2021Chemical Problem; Chemical Problem

  A BIOMEDICAL TECHNICIAN REPORTED TO TECHNICAL SUPPORT THAT A 2008T MACHINE SHOWED LOW CONDUCTIVITY LEVELS WHEN USING A 3K CITRASATE ACID CONCENTRATE DURING SETUP FOR HEMODIALYSIS (HD) TREATMENT. THE ACTUAL CONDUCTIVITY LEVELS WERE 12.9 - 13.0 MS/CM WITH THE THEORETICAL CONDUCTIVITY VALUE OF 13.5 MS/CM. THERE WAS NO PATIENT INVOLVEMENT. UPON FOLLOW UP WITH A USER FACILITY REGISTERED NURSE (RN) IT WAS REPORTED THAT OTHER MACHINES THAT USED JUGS FROM THE SAME BOX DID NOT EXPERIENCE THE REPORTED CONDUCTIVITY ISSUE. HE INDICATED THAT THE MACHINE INVOLVED IN THE EVENT HAD LOW CONDUCTIVITY RESULTS WITH JUGS FROM DIFFERENT BOXES. THE RN INDICATED HE SUSPECTS THE CAUSE OF THE REPORTED ISSUES IS THE MACHINE AND NOT THE PRODUCTS. MULTIPLE ATTEMPTS WERE MADE TO REACH THE BMT, BUT NOT RESPONSE WAS RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 11276610 ↗
• MalfunctionDec 22, 2020Chemical Problem; Chemical Problem

  IT WAS REPORTED A BIOMEDICAL TECHNICIAN (BMT) RECEIVED LOW CONDUCTIVITY VALUES ON A HEMODIALYSIS (HD) MACHINE WITH A LOT OF CITRASATE ACID. UPON FOLLOW UP, THE BMT CLARIFIED THAT THE EVENT OCCURRED WHILE TESTING THE CITRASATE PRIOR TO PATIENT TREATMENT. THE MACHINE ALARMED LOW CONDUCTIVITY AND DISPLAYED A CONDUCTIVITY VALUE OF 13.1 MS/CM. THE THEORETICAL CONDUCTIVITY VALUE WAS SET TO 13.5 MS/CM. SHE CONFIRMED THAT THIS TEST WAS THE FIRST TIME THE REPORTED LOT HAD BEEN USED. THE REMAINING JUGS OF THIS LOT WERE SEQUESTERED AND WERE NOT USED. THE BIOMED IS UNSURE WHICH PART OR LOT NUMBER OF ACID WAS USED SUCCESSFULLY AFTER THE REPORTED INCIDENT. THE CLINIC USES BIBAGS BI-CARBS (UNKNOWN PART AND LOT NUMBER). THERE ARE FOUR CASES OF THE REPORTED LOT REMAINING AT THE CLINIC. THE BMT INDICATED SAMPLES ARE AVAILABLE TO RETURN. A PICKUP WAS SCHEDULED TO RETURN A SAMPLE.

  Patient problems: No Patient Involvement

  MAUDE report 11058518 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY EXPERIENCED LOW CONDUCTIVITY DURING TREATMENT WITH A BATCH OF CITRASATE. UPON FOLLOW UP WITH THE BMT IT WAS REPORTED HE WAS ASKED TO SERVICE THE MACHINE FOR THE LOW CONDUCTIVITY. HE DOES NOT RECALL THE EXACT CONDUCTIVITY VALUES, BUT THE ACTUAL VALUE WAS 0.4 MS/CM BELOW THE THEORETICAL CONDUCTIVITY VALUE. THE MACHINE NEVER REACHED THE THRESHOLD LIMITS TO TRIGGER A BYPASS. THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT WITH THIS BATCH. THERE WAS NO ADVERSE EVENT NOR MEDICAL INTERVENTION ATTRIBUTED TO THIS EVENT. ALL OF THE BATCHES WERE DISCARDED. THE CLINIC WAS USING NATURALYTE DRY BICARB (UNKNOWN LOT).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10931989 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931549 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931541 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931529 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931523 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT, AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931522 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT, AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931519 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931517 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931515 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC, WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931506 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931479 ↗

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