|Date Initiated by Firm
||July 12, 2013
|Date Posting Updated
||September 30, 2013
||Terminated 3 on July 15, 2014
|Recall Event ID
||Prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
||Flixene Grafts >or= 6mm
Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
||Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
| Atrium Medical Corporation
5 Wentworth Dr
Hudson NH 03051-4929
|For Additional Information Contact
||Timothy J. Talcott
|Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
||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 firstname.lastname@example.org
||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 = DSY and Original Applicant = ATRIUM MEDICAL CORP.