BEUDAMED
    FDA Recall Terminated

    Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors

    Recall: Z-0944-2012 · Initiated October 20, 2011

    Recall

    Recall Number
    Z-0944-2012
    Event Number
    60836
    Firm
    Integra LifeSciences Corp
    FEI Number
    1121308
    Product Code
    GWM
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 20, 2011
    Posted
    February 3, 2012
    Terminated
    June 18, 2013
    Address
    105 Morgan Ln, Plainsboro, NJ, 08536-3339

    Description

    Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors

    Reason

    Some of the connector cables associated with Integra's intracerebral pressure (ICP) monitors may cause temporary interference with the ICP waveform on the monitor display.

    Action

    Integra sent a Urgent Product Recall Notification letter dated October 20, 2011, via FedEx, email, and fax to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to examine their inventory at your earliest convenience. If you have an effected PAC1 cable, please complete the attached Recall Acknowledgement Form and return it to Integra Customer Service per the instructions on the form. An Integra Sales Representative will contact you to assist in the return and replacement of new cables at no cost. In the meanwhile, you may continue to use the cables until you have been contacted and replacement product has been provided. Distortion of the ICP wave form can be stopped or prevented by keeping the PACI catheter receptacle out of human contact. Please contact Integra Customer Service at 1-800-654-2873.

    Distribution

    Worldwide Distribution-- USA (nationwide ) .

    Quantity

    221 Units