BEUDAMED
    FDA Recall Terminated

    Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation.

    Recall: Z-2338-2008 · Initiated July 7, 2008

    Recall

    Recall Number
    Z-2338-2008
    Event Number
    48979
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 7, 2008
    Posted
    September 23, 2008
    Terminated
    March 8, 2010
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation.

    Reason

    The parent company became aware of instances where the lower side rail of the frame of the machine broke inwards when being moved across a threshold; resulting in the machine being unstable.

    Action

    The firm has issued a MEDICAL DEVICE RECALL letter dated 7/7/08 to its customers via certified mail. The letter informs them of the problem and to exercise care when using the device until it has been retrofitted. Contact Drager Medical at 1-800-543-5047, #4 for assistance.

    Distribution

    Nationwide

    Quantity

    111 units