BEUDAMED
    FDA Recall 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 · Initiated April 21, 2016

    Recall

    Recall Number
    Z-1812-2016
    Event Number
    73959
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    CAD
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    April 21, 2016
    Terminated
    December 7, 2016
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    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.

    Action

    Drager mailed a "Medical Device Safety Alert" dated April 21, 2016, to customers informing them of the problem and provided instructions for the "correct filling procedure" and recommendations on how to prevent evaporation and spraying of Desflurane after bottle release to resolve the "High Friction of gas bottle valve" problem.

    Distribution

    US nationwide distribution, including Puerto Rico and Guam.

    Quantity

    16078 units distributed within the United States