BEUDAMED
    FDA Enforcement Class II Ongoing

    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.

    Recall: Z-1591-2023 · Reported May 24, 2023

    Enforcement

    Recall Number
    Z-1591-2023
    Event ID
    92026
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Dynasthetics LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2023
    Initiation Date
    May 9, 2022
    Classification Date
    May 16, 2023
    Address
    3487 W 2100 S Ste 300, N/A, Salt Lake City, UT, 84119-5863, United States

    Description

    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.

    Reason

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

    Code Info

    Part Number: 111AU UDI-DI Code: 30858545007012 Lot Number: 0222P

    Distribution

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

    Quantity

    28 filters