Class 2 Device Recall Versaport Bladeless Optical Trocar With Fixation Cannula 5mm
|Date Initiated by Firm
||May 06, 2013
|Date Posting Updated
||June 05, 2013
||Terminated 3 on August 12, 2014
|Recall Event ID
||Laparoscope, general & plastic surgery - Product Code GCJ
||Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm
Product Code: ONB5STF
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.
||Lot Numbers: N2H0353X through N3D0033X, 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
| Covidien LP
60 Middletown Ave
North Haven CT 06473-3908
|For Additional Information Contact
|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.
|Quantity in Commerce
||Worldwide Distribution - USA (nationwide) and internationally to the following countries:
|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)s with Product Code = GCJ and Original Applicant = COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H