BEUDAMED
    FDA Enforcement Class II Terminated

    Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.

    Recall: Z-1468-2013 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1468-2013
    Event ID
    65093
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2013
    Initiation Date
    May 6, 2013
    Classification Date
    June 5, 2013
    Termination Date
    August 12, 2014
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.

    Reason

    Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity

    Code Info

    Lot Numbers: N2h0413X through N3A0391X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela

    Quantity

    23050 units