BEUDAMED
    FDA Enforcement Class II Terminated

    Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular Catheter for use with CSF external drainage systems

    Recall: Z-2909-2016 · Reported October 12, 2016

    Enforcement

    Recall Number
    Z-2909-2016
    Event ID
    75065
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 12, 2016
    Initiation Date
    August 23, 2016
    Classification Date
    September 30, 2016
    Termination Date
    March 29, 2017
    Address
    311 Enterprise Dr, N/A, Plainsboro, NJ, 08536-3344, United States

    Description

    Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular Catheter for use with CSF external drainage systems

    Reason

    During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

    Code Info

    Catalog Number 951303, Lot #0195786 with expiry 05/2019

    Distribution

    Nationwide Distribution to KS only

    Quantity

    14