FDA-Device2013-06-12Class II
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.
Covidien LP
Hazard
Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
Sold states
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
Affected count
23050 units
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1468-2013Don't want to check this manually?
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