BEUDAMED
    FDA Enforcement Class II Ongoing

    Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.

    Recall: Z-0335-2018 · Reported January 24, 2018

    Enforcement

    Recall Number
    Z-0335-2018
    Event ID
    77617
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hamilton Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 24, 2018
    Initiation Date
    June 20, 2017
    Classification Date
    January 12, 2018
    Address
    4990 Energy Way, N/A, Reno, NV, 89502-4123, United States

    Description

    Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.

    Reason

    Issue related to the performance of the motor in recalled product. During use, motor may cease to function.

    Code Info

    Serial No. 1000 thru 2090; P/N 951001

    Distribution

    US Distribution to IL and TX.

    Quantity

    176 units