BEUDAMED
    FDA Recall Terminated

    Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD10

    Recall: Z-2425-2010 · Initiated July 2, 2010

    Recall

    Recall Number
    Z-2425-2010
    Event Number
    56190
    Firm
    Integra LifeSciences Corp
    FEI Number
    1121308
    Product Code
    HAO
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 2, 2010
    Posted
    September 22, 2010
    Terminated
    May 29, 2012
    Address
    105 Morgan Ln, Plainsboro, NJ, 08536-3339

    Description

    Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD10

    Reason

    Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions.

    Action

    All customers and Integra Sales Specialists were notified of the recall on July 2, 2010 by fax, e-mail and letter send by Fed Ex overnight delivery.

    Distribution

    Nationwide, Canada, Taiwan and to Integra, Australia.

    Quantity

    338 units