Centrisol Acid Concentrate SB-143Recalls & reported problems

Medivators Inc. · Centrisol Acid Concentrate · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00677964000577), received between Apr 23, 2021 and Apr 23, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Device Ingredient or Reagent Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 23, 2021Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
THE USER FACILITY REPORTED POSITIVE DETECTION OF OXIDIZING AGENTS IN THEIR DIALYSATE USING CENTRISOL ACID CONCENTRATE LOT 489224. FURTHER CUSTOMER TESTING CONFIRMED THE PRESENCE OF OXIDIZING AGENTS IN THE CENTRISOL ACID CONCENTRATE. NO HARM HAS BEEN REPORTED AS A RESULT OF THIS SITUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11718016 ↗

Device details

UDI-DI	`00677964000577`
Brand	Centrisol Acid Concentrate
Model	SB-143
Catalog no.	67750282
Company	Medivators Inc.
Product code	FKQ · System, Dialysate Delivery, Central Multiple Patient
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jun 7, 2024

Device type (GMDN): Haemodialysis concentrate

A product intended to be mixed with water to prepare a solution with an electrolyte composition similar to that of blood (i.e., a dialysate) for the exchange of solutes with blood through a semi-permeable membrane in the dialyser of a haemodialysis system. It is intended to remove metabolic waste from the blood to help maintain physiological blood electrolyte and pH levels. The product typically includes glucose and salts of the following constituents: sodium, potassium, magnesium, calcium, chloride, and anions of weak acids [e.g., bicarbonate (HCO3), acetate, citrate]. It is supplied as a solution or a dry powder. After application, this device cannot be reused.

Other System, Dialysate Delivery, Central Multiple Patient devices

Centrisol Liquid Bicarbonate Concentrate MB-330-L
Medivators Inc. · System, Dialysate Delivery, Central Multiple Patient
2 deaths5 reports
Centrisol Acid Concentrate SB-352
Medivators Inc. · System, Dialysate Delivery, Central Multiple Patient
2 reports
Centrisol Acid Concentrate SB-353
Medivators Inc. · System, Dialysate Delivery, Central Multiple Patient
1 report

All System, Dialysate Delivery, Central Multiple Patient devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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