Dynasthetics LLC recalls Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from t…

Recall date

May 9, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1591-2023

FDA classification

Class II

Brand / firm

Dynasthetics LLC

Sold / distributed

U.S.: N/A O.U.S.: Australia

Why it was recalled

Due to a manufacturing issue that may result in filter leakage.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from the patient breathing circuit. The device uses two anesthetic vapor adsorbent canisters connected to an anesthesia delivery system to prevent unwanted anesthetic vapors emanating from within an anesthesia gas machine from reaching a patient.