AirLife™ 4893TRecalls & reported problems
Airlife · Tri-Flo™ Suction Cath-N-Glove™ Kit · Class 1
Data updated Oct 16, 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 10190752148956), received between Feb 6, 2025 and Feb 6, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Packaging 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Packaging Problem1
Patient problems
- Bacterial Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2025Packaging Problem; Packaging Problem
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030673-2025-00007 FOR THE FIRST REPORT IT WAS REPORTED, THE SUCTION CATHETER WAS CONTAMINATED WITH A [UNKNOWN] BLACK MATERIAL. UPON DISCOVERY, A NEW CLOSED SUCTION SYSTEM WAS PLACED. [THE DISCOVERY MAY HAVE LEAD TO] A DELAY IN SUCTIONING. IT WAS ADDITIONALLY REPORTED, THE PATIENT WAS POSITIVE FOR SERRATIA (WATER BACTERIA) IN THEIR ENDOTRACHEAL TUBE. AT THE TIME OF THE REPORT, THE PATIENT WAS VENTED, AND IN ISOLATION FOR POSITIVE CULTURES FOR SERRATIA.
Patient problems: Bacterial Infection
MAUDE report 21329455 ↗
Other Airway suction kit devices
- AirLife™ 4698TAirlife · Airway Suction Kit1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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