BEUDAMED
    FDA Recall Terminated

    NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit

    Recall: Z-0339-06 · Initiated September 8, 2005

    Recall

    Recall Number
    Z-0339-06
    Event Number
    33451
    Firm
    Integra Neuro Sciences
    FEI Number
    2023988
    Product Code
    GWM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 8, 2005
    Posted
    January 6, 2006
    Terminated
    March 7, 2012
    Address
    5955 Pacific Center Blvd, San Diego, CA, 92121-4309

    Description

    NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit

    Reason

    Certain Model NS-P probes contained in the NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit may allow an Intracranial Pressure (ICP) drift of up to 5 mmHg during the first 24 hours of monitoring ICP. This is outside the products labeling specification of 2 mmHg maximum ICP drift within the first 24 hours of monitoring.

    Action

    Notify Customers and Sales Representatives who received the product by letter sent via Federal Express. Customers will be instructed that an Integra Sales Representative will contact them to arrange for return of affected product.

    Distribution

    Nationwide

    Quantity

    79