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U.S. Department of Health and Human Services

Class 2 Device Recall Flixene Trumpet Grafts

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  Class 2 Device Recall Flixene Trumpet Grafts see related information
Date Initiated by Firm July 12, 2013
Date Posted September 30, 2013
Recall Status1 Terminated 3 on July 15, 2014
Recall Number Z-2314-2013
Recall Event ID 65697
510(K)Number K071923  
Product Classification Prosthesis, vascular graft, of less then 6mm diameter - Product Code DSY
Product Flixene Trumpet Grafts >or= 6mm
Flixene GW and GWT Grafts >or= 6mm
Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Code Information Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
Recalling Firm/
Manufacturer		 Atrium Medical Corporation
5 Wentworth Dr
Hudson NH 03051-4929
For Additional Information Contact Timothy J. Talcott
603-880-1433
Manufacturer Reason
for Recall		 Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
FDA Determined
Cause 2		 Package design/selection
Action Atrium Medical Corporation issued an Urgent Medical Device Safety Alert letter on July 16, 2013, via UPS to customers and e-mail to the field representatives that represent these accounts. The notification identifies the problem, product, and risk factors. In addition, it provides instructions how to handle product that may be affected. For questions customers were instructed to contact their Atrium Medical Customer Service at 603-880-1433 Prompt 1 or by e-mail at returns@atriummed.com
Distribution Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia
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 = DSY and Original Applicant = ATRIUM MEDICAL CORP.
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