HUDSON RCI IPN913731Recalls & 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
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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
- 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-1113-2020 · Root cause: Device Design · Recall details · FDA record ↗
Other Humidifier nebulizer kit devices
- HUDSON RCI HUD88015KITMedline Industries, Inc. · Humidifier nebulizer kit1 recall15 reports
- HUDSON RCI IPN913730Teleflex Incorporated · Humidifier nebulizer kit1 recall1 report
- Seattle PAP plus MP02260Drägerwerk AG & Co. KGaA · Humidifier Nebulizer Kit1 recall0 reports
- HUDSON RCI HUD88013KITMedline Industries, Inc. · Humidifier nebulizer kit1 recall0 reports
- HUDSON RCI HUD88014KITMedline Industries, Inc. · Humidifier nebulizer kit1 recall0 reports
- HUDSON RCI HUD88017KITMedline Industries, Inc. · Humidifier nebulizer kit1 recall0 reports
- HUDSON RCI HUD78001KITMedline Industries, Inc. · Humidifier nebulizer kit1 recall0 reports
- HUDSON RCI HUD78018KITMedline Industries, Inc. · Humidifier nebulizer kit1 recall0 reports
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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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