Centrisol Acid Concentrate SB-353Recalls & reported problems

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 00677964091766), received between Sep 25, 2024 and Sep 25, 2024 — classified as 1 malfunction.

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

No Apparent Adverse Event1

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.

MalfunctionSep 25, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE USER FACILITY REPORTED VIA MEDWATCH REPORT MW5157962 THAT THEIR SB-352 AND SB-353 JUGS OF CENTRISOL ACID CONCENTRATE HAD THE SAME COLOR AND STYLE LABELS. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20304267 ↗

Device details

UDI-DI	`00677964091766`
Brand	Centrisol Acid Concentrate
Model	SB-353
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	In Commercial Distribution
Record updated	Oct 16, 2023

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-143
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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