HUDSON RCI IPN049113Recalls & reported problems
Teleflex Incorporated · AQUAPAK Sterile Water for Inhalation 340 mL w/ 040 Humidifier Adaptor · Class 2
All models of HUDSON RCI (152)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704627568), received between Apr 5, 2021 and Apr 5, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (2 reports).
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.
Most reported problems
Device problems
- Connection Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 5, 2021Connection Problem; Connection Problem
IT WAS REPORTED THAT "NICU HAD A NEW ADMISSION THAT REQUIRED HUMIDIFICATION. AQUAPAK HUMIDIFIER ADAPTOR DID NOT SCREW ONTO THE OXYGEN POINT. ADAPTOR DOES NOT THREAD. CLINICAL CONSEQUENCES: A NEW PACK WAS OPENED AND USED SUCCESSFULLY. NO PATIENT INVOLVEMENT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11615857 ↗MalfunctionApr 5, 2021Connection Problem; Connection Problem
IT WAS REPORTED THAT "AQUAPAK HUMIDIFIER ADAPTOR IS FAULTY AND WOULD NOT SCREW OR FIT ON TO THE FLOW METER. CLINICAL CONSEQUENCES: NONE - PRIOR TO USE ON PATIENT DURING INSPECTION/FUNCTIONAL TESTING".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11613181 ↗
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 IPN913731Teleflex Incorporated · 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
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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