BEUDAMED
    FDA Enforcement Class II Terminated

    Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the ventricles of the brain.

    Recall: Z-1984-2012 · Reported July 18, 2012

    Enforcement

    Recall Number
    Z-1984-2012
    Event ID
    62138
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 18, 2012
    Initiation Date
    April 4, 2012
    Classification Date
    July 10, 2012
    Termination Date
    August 2, 2012
    Address
    105 Morgan Ln, Plainsboro, NJ, 08536-3339, United States

    Description

    Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the ventricles of the brain.

    Reason

    The pouch label of catalog NL850-1330 indicates an incorrect model and closing pressure of the device. The incorrect label reads: "Model: 12 mm-Medium Pressure" instead of "Model: 16 mm-Low Pressure".

    Code Info

    1115647, 1115939, 1120413

    Distribution

    International Only Distribution, including the countries of Thailand and Japan.

    Quantity

    39 units