BEUDAMED
    FDA Recall Terminated

    Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.

    Recall: Z-1963-2015 · Initiated June 1, 2015

    Recall

    Recall Number
    Z-1963-2015
    Event Number
    71434
    Firm
    Hamilton Medical, Inc.
    FEI Number
    2937708
    Product Code
    BZO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 1, 2015
    Posted
    July 2, 2015
    Terminated
    August 12, 2015
    Address
    4990 Energy Way, Reno, NV, 89502-4123

    Description

    Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.

    Reason

    An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement and decrease the amount of ventilation delivered.

    Action

    Hamilton Medical Inc sent a Medical Device Safety Notices letter dated May 8, 2015 by traceable method to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact Technical Support Manager at 800-426-6331, Ext 215.

    Distribution

    US Nationwide Distribution.

    Quantity

    154 total - all part numbers