BEUDAMED
    FDA Recall Terminated

    INTEGRA NeuroSensor Probe, REF NS-P, component of Cerebral Blood Flow and Intracranial Pressure Monitoring Kit, Integra NeuroSciences

    Recall: Z-1191-2008 · Initiated January 28, 2008

    Recall

    Recall Number
    Z-1191-2008
    Event Number
    46788
    Firm
    Integra Neuro Sciences
    FEI Number
    2023988
    Product Code
    GWM
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    January 28, 2008
    Posted
    August 5, 2008
    Terminated
    April 22, 2010
    Address
    5955 Pacific Center Blvd, San Diego, CA, 92121-4309

    Description

    INTEGRA NeuroSensor Probe, REF NS-P, component of Cerebral Blood Flow and Intracranial Pressure Monitoring Kit, Integra NeuroSciences

    Reason

    Incorrect pressure reading: Due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg could be exceeded by up to -3mmHg, that could result in a maximum Insertion Error of +/- 6mmHg.

    Action

    Integra NeuroSciences sent a Recall Notification with a Recall Acknowledgement form to all customers with product currently in their possession through an Integra Field Sales Repesentative on January 28, 2008. The notification advises that the firm has determined that due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg could be exceeded by up to -3mmHg that could result in a maximum Insertion Error of +/- 6mmHg. Customers are asked to examine their inventory immediately to determine if they have any NeuroSensor Model NS-P's lot #100063 on hand and if so to not use the product. Customers are advised to contact their local Integra representative for further assistance. The letter advises that the lot/serial number is located on a white 1/2" x 1/2" label on the large beige optical connector, and can readily be seen through the bottom of the product tray packaging. The letter also advises that this recall pertains to NeuroSensor Model NS-P's, lot # 100063 -all serial numbers. A response form is included. In addition, the Field Sales Representatives have been instructed to physically remove all lot 100063 of NeuroSensor Probes from inventory and provide replacement product.

    Distribution

    USA Distribution: CA, GA, NM, TX, NE, WA, and NY.

    Quantity

    43 units