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U.S. Department of Health and Human Services

Class 2 Device Recall Versaport Bladeless Optical Trocar With (2) Fixation Cannulae 5mm

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  Class 2 Device Recall Versaport Bladeless Optical Trocar With (2) Fixation Cannulae 5mm see related information
Date Initiated by Firm May 06, 2013
Date Posted June 05, 2013
Recall Status1 Terminated 3 on August 12, 2014
Recall Number Z-1470-2013
Recall Event ID 65093
510(K)Number K112349  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product 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.
Code Information 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
Recalling Firm/
Manufacturer		 Covidien LP
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact
203-492-8165
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		 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 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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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