UNIVERSAL F2®ANESTHESIA BREATHING CIRCUIT LC395-6121ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00612649212166), received between Nov 12, 2021 and Nov 12, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionNov 12, 2021Product Quality Problem; Detachment of Device or Device Component

  ELBOW GAS SAMPLING PORT ON THE KING/AMBU UNIVERSAL BREATHING CIRCUIT CAME LOOSE AFTER 4-HOUR PROCEDURE AND WE WERE UNABLE TO RE-SEAT THE CAP. PREVIOUSLY, THIS WAS A LUER-LOCK CAP, BUT IT HAS RECENTLY CHANGED BY THE MANUFACTURER TO BE A PUSH-ON CAP. MANUFACTURER RESPONSE FOR CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE), UNIVERSAL F2 ANESTHESIA BREATHING CIRCUIT (PER SITE REPORTER): THEY WILL INVESTIGATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804980 ↗