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HUDSON RCI IPN913728Recalls & reported problems

Teleflex Incorporated · COMFORT FLO Humidification System · Class 2

All models of HUDSON RCI (152)

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

Adverse event reports
4
Deaths reported
0
Injuries reported
2
Recalls naming it
1

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14026704659347), received between Mar 1, 2021 and Sep 14, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Overfill” (3 reports).

1 FDA recall record name this device's identifier.

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. Dec 13, 2019Class ITerminated

    There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.

    Z-1114-2020 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Overfill3
  • Improper Flow or Infusion1

Patient problems

  • Low Oxygen Saturation2
  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 14, 2021Overfill; Overfill

    IT WAS REPORTED ""RT [RESPIRATORY THERAPIST] FOUND THE HF COLUMN BUBBLING WATER INTO THE CIRCUIT". IT WAS REPORTED THE CIRCUIT WAS C HANGED. NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12470920 ↗
  • MalfunctionApr 28, 2021Improper Flow or Infusion; Improper Flow or Infusion

    IT WAS REPORTED "CUSTOMER CLAIMS THE 2410 CIRCUIT + COLUMN ARE "SQUIRTING WATER INTO THE CIRCUIT WHEN RUNNING AT 30LPM". RT WAS SETTING THIS SYSTEM FOR HIGH FLOW, PRIOR TO THE PATIENT, AND IT WAS TURNED UP TO 30 LPM, AND WATER WAS SQUIRTING INTO THE CIRCUIT". NO PATIENT INVOLVEMENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11740710 ↗
  • InjuryMar 2, 2021Overfill; Overfill

    IT WAS REPORTED "THE HEATING COLUMN ON CIRCUIT 2410 "BUBBLED OVER" AND FLOODED THE CIRCUIT, AND ENDED UP SENDING HOT WATER TO THE PATIENTS NOSE. THE PATIENTS O2 SATURATION LEVEL DROPPED, AND A NEW CIRCUIT WAS PUT ON, AND THEY IMPROVED RIGHT AFTER". PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: Low Oxygen Saturation

    MAUDE report 11400416 ↗
  • InjuryMar 1, 2021Overfill; Overfill

    IT WAS REPORTED "THE HEATING COLUMN ON CIRCUIT 2410 "BUBBLED OVER" AND FLOODED THE CIRCUIT, AND ENDED UP SENDING HOT WATER TO THE PATIENTS NOSE. THE PATIENTS O2 SATURATION LEVEL DROPPED, AND A NEW CIRCUIT WAS PUT ON, AND THEY IMPROVED RIGHT AFTER". PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: Low Oxygen Saturation

    MAUDE report 11395110 ↗

Other HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) devices

All HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) devices →

Sources and updates

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