BEUDAMED
    FDA Recall Terminated

    Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set.

    Recall: Z-0431-06 · Initiated November 28, 2005

    Recall

    Recall Number
    Z-0431-06
    Event Number
    34203
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    LFL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 28, 2005
    Posted
    January 24, 2006
    Terminated
    February 26, 2007
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set.

    Reason

    Additional Model 24kHz Tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues. (2nd recall, same problem see Z-141-6)

    Action

    Customers were notified of the recall on 11/28/2005 via letter sent by UPS.

    Distribution

    The device is distributed nationwide to hospitals nationwide.

    Quantity

    536 units