Expiratory valve set 160245Recalls & reported problems

Hamilton Medical AG · Expiratory valve set for HAMILTON-C2/C3/C6, adult/pediatric, autoclavable · 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 07630002801133), received between Jan 26, 2023 and Jan 26, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (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.

Most reported problems

Device problems

Gas/Air Leak1
Obstruction of Flow1

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.

MalfunctionJan 26, 2023Obstruction of Flow; Gas/Air Leak; Obstruction of Flow; Gas/Air Leak
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: REUSABLE EXPIRATORY VALVE (PN:160245) FOR HAMILTON-C6 AFTER THE REPROCESSING PROCESS, THE MEMBRANE STICKS TO THE VALVE BODY, WHICH IS NOT CHECKED DURING THE LEAK TEST. AN OCCLUSION ALARM APPEARS IMMEDIATELY WHEN VENTILATION IS STARTED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16245917 ↗

Device details

UDI-DI	`07630002801133`
Brand	Expiratory valve set
Model	160245
Company	Hamilton Medical AG
Product code	BYX · Tubing, Pressure And Accessories
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 16, 2022

Device type (GMDN): Mechanical expiratory valve, reusable

A non-sterile mechanical device intended to be used in a respiratory or anaesthesia breathing circuit to maintain a degree of positive pressure in a patient's airway at the end of expiration. Typically constructed of plastic/metal it has a valve that is actuated by a spring to provide expiratory airway resistance, and an adjustable knob (usually not graduated) that is typically set between 0 and 20 cmH20 pressure, but may be fully closed when controlled/assisted ventilation is applied. It is normally used with anaesthesia breathing systems, pulmonary resuscitators, or ventilators and is commonly known as a pop-off valve, relief valve, or spill valve. This is a reusable device.

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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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