AirLife 5257Recalls & reported problems
Carefusion Corporation · Airlife™ Modudose™ 0.9% Sodium Chloride Solution, USP, 5 ml · Class 2
All models of AirLife (23)
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 20885403164849), received between Oct 8, 2020 and Mar 2, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
- Material Too Rigid or Stiff1
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.
MalfunctionMar 2, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff
THE CUSTOMER REPORTED THAT THE AIRLIFE¿ MODUDOSE¿ 0.9% SODIUM CHLORIDE SOLUTION, USP 5 ML IS MOLDED TOGETHER AND WILL NOT BREAK APART FOR SINGLE USE. THERE ARE 4 SINGLES MOLDED TOGETHER AND MUST BE CUT APART WITH A BOX CUTTER TO USE. THE CUSTOMER CONFIRMED THAT THERE WAS NO HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11399874 ↗MalfunctionOct 8, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED TO VYAIRE MEDICAL BY A PRIVATE CONSUMER THAT SHE FEELS THAT THE AIRLIFE MODUDOSE 0.9% SODIUM CHLORIDE SOLUTION, USP 5 ML MAY BE LEACHING THROUGH PLASTIC CONTAINERS DURING STORAGE OR TRANSIT. THE CUSTOMER IS HIGHLY SENSITIVE TO CHEMICALS, HAVING AUTOIMMUNE MAST CELL DISEASE. SHE IS UNABLE TO USE THE NEBULIZER AS INSTRUCTED SINCE IT DOES NOT SMELL NORMAL AND SHE CAN SMELL AND TASTE A CHEMICAL SMELL WHEN SHE PERFORMS THE NEBULIZER. AS OF THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10652991 ↗
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- 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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