PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: June 12, 2013 Initiated: May 6, 2013 #Z-1470-2013

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Covidien LP
Units Affected
5364 units
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
Location
North Haven, CT

Frequently Asked Questions

What product was recalled?
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.. Recalled by Covidien LP. Units affected: 5364 units.
Why was this product recalled?
Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
Which agency issued this recall?
This recall was issued by the FDA Devices on June 12, 2013. Severity: Moderate. Recall number: Z-1470-2013.