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U.S. Department of Health and Human Services

Class 2 Device Recall Versaport Bladeless Optical Trocar With Fixation Cannula 5mm Short

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 Class 2 Recall
Versaport Bladeless Optical Trocar With Fixation Cannula 5mm Short
see related information
Date Posted June 05, 2013
Recall Status1 Terminated on August 12, 2014
Recall Number Z-1468-2013
Recall Event ID 65093
Premarket Notification
510(K) Number
K112349 
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product 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.
Code Information Lot Numbers: N2h0413X through N3A0391X 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
Recalling Firm/
Manufacturer
Covidien LP
60 Middletown Ave
North Haven, Connecticut 06473-3908
Manufacturer Reason
for Recall
Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
FDA Determined
Cause 2
DESIGN: Device Design
Action 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.
Quantity in Commerce 23050 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
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