BEUDAMED
    FDA Recall Terminated

    Integra, Licox Ref 1P2.P; Brain PMO-Probe Kit Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain probes, REF CC1/P1 Combined Oxygen & Temperature Probe. Contents Sterile and Non-Pyrogenic if package is unopened and undamaged.

    Recall: Z-1422-2010 · Initiated February 18, 2010

    Recall

    Recall Number
    Z-1422-2010
    Event Number
    54769
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    GWM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 18, 2010
    Posted
    April 20, 2010
    Terminated
    April 20, 2010
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Integra, Licox Ref 1P2.P; Brain PMO-Probe Kit Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain probes, REF CC1/P1 Combined Oxygen & Temperature Probe. Contents Sterile and Non-Pyrogenic if package is unopened and undamaged.

    Reason

    One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center.

    Action

    An Integra NeuroSpecialist was sent to retrieve the probe on February 18, 2010, followed by a formal letter.

    Distribution

    One hospital in Omaha, NE.

    Quantity

    1