AirLife™ CN4505Recalls & reported problems
Airlife · AirLife ™ 0.45% Sodium Chloride Inhalation Solution, USP · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752141766), received between Jun 27, 2023 and Jun 27, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Contamination /Decontamination Problem1
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.
MalfunctionJun 27, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT WHITE FLUFFY PARTICLES WERE FOUND ONLY IN ONE BOTTLE OF SODIUM CHLORIDE SOLUTION 0.45% 500ML AND THE CUSTOMER WANTS TO KNOW THE IDENTITY OF THE PARTICLES IN ORDER TO MAKE SURE THEY ARE TRULY INORGANIC. (VS. MICRO-ORGANISM). IT SEEMS THE CUSTOMER DISCOVERED THE FLOATERS WHILE IN USE OF THIS SALINE. SHE THEN SUB-CULTURED (NEGATIVE GROWTH) A SAMPLE AND KEPT USING TILL THE END. THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17206384 ↗
Other Nebulizer (direct patient interface) devices
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- Circulaire™ 0330Sunmed, LLC · Nebulizer (Direct Patient Interface)1 recall0 reports
- I neb 00Respironics Respiratory Drug Delivery (Uk) Ltd · NEBULIZER (DIRECT PATIENT INTERFACE)3 deaths15 reports
- VixOne 0209Westmed, Inc. · Nebulizer (Direct Patient Interface)13 reports
- HUDSON RCI IPN040620Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)12 reports
- HUDSON RCI IPN049808Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)6 reports
- HUDSON RCI HUD05014Medline Industries, Inc. · Nebulizer (direct patient interface)6 reports
- VixOne 0210Westmed, Inc. · Nebulizer (Direct Patient Interface)5 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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