BEUDAMED
    FDA Enforcement Class II Terminated

    Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.

    Recall: Z-1954-2018 · Reported June 6, 2018

    Enforcement

    Recall Number
    Z-1954-2018
    Event ID
    80027
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 6, 2018
    Initiation Date
    April 26, 2018
    Classification Date
    May 29, 2018
    Termination Date
    September 7, 2018
    Address
    3135 Quarry Rd, N/A, Telford, PA, 18969-1042, United States

    Description

    Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.

    Reason

    The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.

    Code Info

    Serial nos. ASKM-0065 ASKM-0066 ASKM-0106 ASKM-0134 ASKM-0137 ASKM-0150 ASKM-0151 ASKN-0009

    Distribution

    Distributed to the states of CT, IL, MN, NV, SD, and WA.

    Quantity

    8 units