FDAFDA · Alimentos y medicamentos·N.º oficial Z-1470-2013
Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C 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.
Publicado el 12 de junio de 2013 · Inicio del retiro: 6 de mayo de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Covidien LP
- Distribuidor
- 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
- Lote
- Lot Numbers: N2J0211X through N3D0118X 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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