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3.0 Liter Disposable Set 903-00032Recalls & reported problems

Belmont Instrument Corporation · Class 2

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00896128002534), received between Oct 14, 2021 and Oct 14, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Increase in Pressure” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K242735); they may or may not involve this specific model.

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.

Recalls naming this device

  1. Mar 31, 2025Class IIOpen, Classified

    Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.

    Z-1678-2025 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Increase in Pressure1
  • Insufficient Flow or Under Infusion1
  • Obstruction of Flow1

Patient problems

  • Thrombosis/Thrombus1

Recent adverse event reports

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

  • MalfunctionOct 14, 2021Increase in Pressure; Insufficient Flow or Under Infusion; Obstruction of Flow; Increase in Pressure; Insufficient Flow or Under Infusion; Obstruction of Flow

    ON SEPTEMBER 16, 2021, BELMONT MEDICAL TECHNOLOGIES RECEIVED A REPORT FROM THE DISTRIBUTOR THAT THE RAPID INFUSER, FMS2000 BEGAN ALARMING "HIGH PRESSURE" DURING A TRANSFUSION. IT WAS REPORTED THAT EXAMINATION OF THE DISPOSABLE SET REVEALED CLOTTING IN THE TUBING AND RESERVOIR. BELMONT MEDICAL TECHNOLOGIES RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE DISTRIBUTOR ON SEPTEMBER 27, 2021: "CASE: (B)(6), RECURRENCE C THYROID FOR SURGERY CLOSE TO A CAROTIS WITH ACCIDENTAL LESION AND LIFE-THREATENING BLEEDING, WHICH IS WHY HYPERACUTE DELIVERY AND TRANSFUSION IS STARTED WITH ACUTE TRANSFUSION PACK (4 SAGM, 4 FFP, 2 TK) A TOTAL OF 3 PIECES (THE FIRST 2 ARE GIVEN) , THE COLD SAGM / FFPS ARE COLLECTED IN THE BELMONT RESERVOIR AND DURING FLOW CLOTS DEVELOP IN A SHORT TIME. BOTH BEFORE AND AFTER THE FILTER IN THE RESERVOIR, IN THE HEATING CIRCLE OF THE INFUSION TUBE AND ALL THE WAY TO THE PATIENT. THE CONSEQUENCE FOR PATIENTS WAS THE DEVELOPMENT OF PULMONARY EMBOLISM AND DELAYED TRANSFUSION IN HYPERACUTE SITUATION. THE PATIENT IS WELL, NO SEQUELAE AFTER THE EPISODE, IS DISCHARGED AND IN 3 MONTHS OF TREATMENT FOR PULMONARY EMBOLISM, AND FULLY INFORMED OF THE INCIDENT AND COMPLICATION. T

    Patient problems: Thrombosis/Thrombus

    MAUDE report 12636767 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K242735. One submission often covers many models, so check the product and lot details in each record.

  • Z-1099-2025 · Jan 2, 2025 · Open, Classified
    Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warm

Other Warmer, Thermal, Infusion Fluid devices

All Warmer, Thermal, Infusion Fluid devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page