BEUDAMED
    FDA Recall 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 · Initiated April 4, 2012

    Recall

    Recall Number
    Z-1984-2012
    Event Number
    62138
    Firm
    Integra LifeSciences Corp
    FEI Number
    1121308
    Product Code
    JXG
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    April 4, 2012
    Posted
    July 10, 2012
    Terminated
    August 2, 2012
    Address
    105 Morgan Ln, Plainsboro, NJ, 08536-3339

    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".

    Action

    The firm initiated a voluntary recall by notifying the two consignees initially via email and then with an "URGENT: MEDICAL DEVICE RECALL" dated April 5th or 9th, 2012. The letter informed them of the labeling error and provided instructions regarding affected product. The International Customer Service number was provided 609-936-5400.

    Distribution

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

    Quantity

    39 units