Tube set for suction, single-use AQL-111Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056702002190), received between Dec 2, 2019 and Dec 2, 2019 — 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2019Tear, Rip or Hole in Device Packaging; Packaging Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "(B)(6) REPORTS SHE HAS AQUILEX TUBING OF LOTS K18G175 AND K18K265 THAT APPEAR TO HAVE TINY PIN HOLES IN THE PACKAGE AND SOME SORT OF TINY PARTICLES RUBBING FROM INSIDE CREATING THESE HOLES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9394564 ↗