AirLife™ T261CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752145511), received between Jul 28, 2023 and Jul 28, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2023Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE PEELABLE PACKAGING OF T261C - CATHETER SUCT PH CONT 10FR TRI-FLO STRT WAS DIFFICULT TO OPEN BECAUSE LINE OF SEALANT TOO CLOSE TO THE END OF THE PACKAGING WHICH PREVENTS THE TWO LAMINATED PAPERS FROM BEING SEPARATED (BOTTOM AND TOP OF THE PACKAGING). ALSO, WHEN THE TIME TO USE THE PRODUCT IS MUCH TOO LONG BECAUSE IT IS OFTEN USED IN THE EMERGENCY ROOM, THERE IS A RISK OF INCREASED CONTAMINATION FOR STERILE SUCTION. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM/INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17419658 ↗
• MalfunctionJul 28, 2023Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE PEELABLE PACKAGING OF T261C - CATHETER SUCT PH CONT 10FR TRI-FLO STRT WAS DIFFICULT TO OPEN BECAUSE LINE OF SEALANT TOO CLOSE TO THE END OF THE PACKAGING WHICH PREVENTS THE TWO LAMINATED PAPERS FROM BEING SEPARATED (BOTTOM AND TOP OF THE PACKAGING). ALSO, WHEN THE TIME TO USE THE PRODUCT IS MUCH TOO LONG BECAUSE IT IS OFTEN USED IN THE EMERGENCY ROOM, THERE IS A RISK OF INCREASED CONTAMINATION FOR STERILE SUCTION. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM/INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17419657 ↗