Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH 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
- Recall Number
- Z-1471-2013
- Event Number
- 65093
- FEI Number
- 1219930
- Product Code
- GCJ
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- May 6, 2013
- Posted
- June 5, 2013
- Terminated
- August 12, 2014
- Address
- LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908
Description
Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH 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.
Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
Covidien sent an Urgent Medical Device Recall letter dated May 6, 2013,via federal express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the product and return all inventory to Covidien Surgical Solutions, 195 McDermott Road, North Haven, CT 06473. Customers were requested to return completed Response Form. Customers with questions were instructed to contact their Covidien representative or Covidien Customer Service, Monday through Friday, Sam - 6:30pm ET, at (800) 962-9888, option 1, and then option 2. For questions regarding this recall call 203-492-8165.
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
2705 units