FDAFDA · Food and drugs·Recall number Z-1469-2013
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF 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.
Published June 12, 2013 · Recall initiated: May 6, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien LP
- Distributor
- 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
- Lot
- Lot Numbers: N2H0353X through N3D0033X 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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