AirLife™ AL4109Recalls & reported problems
Airlife · Sterile 0.9% Sodium Chloride for Irrigation, USP, 110 ml · 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 10190752130401), received between Jun 29, 2023 and Jun 29, 2023 — classified as 1 malfunction.
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
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 29, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE THREE BOTTLES OF SALINE 0.9% DUALTOP PLAST BT 110ML 25/CS ARE LEAKING. THE SEAM ON EACH BOTTLE IS DEFECTIVE AND IF THE CUSTOMER MOVES A BIT, THE BOTTLE SPRAY FROM THE NOZZLE. FURTHERMORE, THERE IS NO PATIENT ASSOCIATED WITH THE SAID EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17232647 ↗
Other CATHETER AND TIP, SUCTION devices
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- Wayne G56537Cook Incorporated · CATHETER AND TIP, SUCTION2 recalls33 reports
- Bard® Suction Connector EN0066000C. R. Bard, Inc. · CATHETER AND TIP, SUCTION1 recall6 reports
- Medline Industries, Inc. OR929KMedline Industries, Inc. · CATHETER AND TIP, SUCTION1 recall0 reports
- MEDLINE DYND41476Medline Industries, Inc. · CATHETER AND TIP, SUCTION1 recall0 reports
- ARROW IPN039282Teleflex Incorporated · CATHETER AND TIP, SUCTION1 recall0 reports
- Argyle 10102Cardinal Health 200, LLC · CATHETER AND TIP, SUCTION1 recall0 reports
- Argyle 12082Cardinal Health 200, LLC · CATHETER AND TIP, SUCTION1 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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