AirLife CK0010Recalls & reported problems
Carefusion Corporation · Airlife™ Prefill Nebulizer Kit Nebulizer Cap and Sterile Water for Inhalation, USP, 1000 ml · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403221484), received between Feb 5, 2021 and Sep 3, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Defective Device1
- Infusion or Flow Problem1
Patient problems
- Airway Obstruction1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2021Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT OUR CK0010 NEB KIT W ADAPTER STERILE WATER 1000ML WAS NOT MISTING. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12424979 ↗InjuryFeb 5, 2021Defective Device; Defective Device
THE CUSTOMER REPORTED THAT THE NEB KIT W ADAPTER STERILE WATER 1000ML QUITS NEBULIZING AND THEY HAVE HAD KIDS TRACHEOSTOMY PLUG OFF AND THEY THEN DECOMPENSATE. PATIENT AIRWAY WAS OBSTRUCTED BY SECRETIONS. AS AN INTERVENTION, THE PATIENT JUST HAD TO BE AGGRESSIVELY SUCTIONED TO CLEAR OUT AIRWAY.
Patient problems: Airway Obstruction
MAUDE report 11289315 ↗
Other Humidifier nebulizer kit devices
- HUDSON RCI HUD88015KITMedline Industries, Inc. · Humidifier nebulizer kit1 recall15 reports
- HUDSON RCI IPN913730Teleflex Incorporated · Humidifier nebulizer kit1 recall1 report
- HUDSON RCI IPN913731Teleflex Incorporated · Humidifier nebulizer kit1 recall0 reports
- HUDSON RCI HUD78001KITMedline Industries, Inc. · Humidifier nebulizer kit1 recall0 reports
- HUDSON RCI HUD88013KITMedline Industries, Inc. · Humidifier nebulizer kit1 recall0 reports
- HUDSON RCI HUD88017KITMedline Industries, Inc. · Humidifier nebulizer kit1 recall0 reports
- Seattle PAP plus MP02260Drägerwerk AG & Co. KGaA · Humidifier Nebulizer Kit1 recall0 reports
- HUDSON RCI HUD78018KITMedline Industries, Inc. · Humidifier nebulizer kit1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.