—#119922

Product

Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

FDA product code: DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K010516
Affected lot / code info: Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.

Why it was recalled

Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field

Root cause (FDA determination)

Package design/selection

Action the firm took

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

Recalling firm

Firm: Atrium Medical Corporation
Address: 5 Wentworth Dr, Hudson, New Hampshire 03051-4929

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2013-07-12
Posted by FDA: 2013-09-30
Terminated: 2014-07-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119922. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.