BEUDAMED
    FDA Recall Terminated

    "***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile for Single Use Only***Size 0.031" OD, Total Length: 8"***Plainsboro, NJ***" Stainless steel stylet for ventricular catheter

    Recall: Z-1047-201 · Initiated November 28, 2011

    Recall

    Recall Number
    Z-1047-201
    Event Number
    60599
    Firm
    Integra Neurosciences PR, Inc. Carr
    FEI Number
    3000204775
    Product Code
    JXG
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    November 28, 2011
    Posted
    February 16, 2012
    Terminated
    October 29, 2013
    Address
    402 Norte Km 1.2, Anasco, PR, 00610

    Description

    "***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile for Single Use Only***Size 0.031" OD, Total Length: 8"***Plainsboro, NJ***" Stainless steel stylet for ventricular catheter

    Reason

    The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.

    Action

    Integra sent an Urgent Product Recall Notification letter dated November 28, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out and sign the attached Recall Acknowledgement Form noting the part numbers, lot numbers and quantity of the affected product in their inventory. Customers were asked to contact Integra LifeSciences Corporation International Customers Service at 609-936-5400 to arrange for Returns. If customers do not have any of the affected product in their inventory they are required to complete and sign the form and indicate they have NO affected product in their inventory. Customers should fax or email their Recall Acknowledgement Form to: 609-750-4259 or [email protected] For questions call 609-936-2495.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Austria, Canada, Italy, Australia

    Quantity

    241 units