BEUDAMED
    FDA Enforcement Class II Terminated

    Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer

    Recall: Z-1812-2016 · Reported June 1, 2016

    Enforcement

    Recall Number
    Z-1812-2016
    Event ID
    73959
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 1, 2016
    Initiation Date
    April 21, 2016
    Classification Date
    May 25, 2016
    Termination Date
    December 7, 2016
    Address
    3135 Quarry Rd, N/A, Telford, PA, 18969-1042, United States

    Description

    Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer

    Reason

    Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure. Eye contact with volatile anesthetics can result in serious irritation. Immediate eye flushing and consultation of a physician is recommended. Updated Material Safety Data Sheets (MSDS) for Desflurane recommend wearing safety glasses when handling these substances.

    Code Info

    Catolog Number M35500 (D-Vapor) M36700 (D-Vapor 3000) Distributed October 2004  April 2016

    Distribution

    US nationwide distribution, including Puerto Rico and Guam.

    Quantity

    16078 units distributed within the United States