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HUDSON RCI IPN913730Recalls & reported problems

Teleflex Incorporated · COMFORT FLO · Class 2

All models of HUDSON RCI (152)

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

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 14026704659361), received between Apr 30, 2021 and Apr 30, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Improper Flow or Infusion” (1 report).

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-1112-2020 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Improper Flow or Infusion1

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 30, 2021Improper Flow or Infusion; Improper Flow or Infusion

    IT WAS REPORTED "THE COVID PATIENT IS SELF PRONING. WHEN HE FLIPPED OVER WATER SQUIRTED ALL OVER THE ROOM". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11752420 ↗

Other Humidifier nebulizer kit devices

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Sources and updates

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