BEUDAMED
    FDA Recall Terminated

    Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

    Recall: Z-2309-2013 · Initiated July 12, 2013

    Recall

    Recall Number
    Z-2309-2013
    Event Number
    65697
    Firm
    Atrium Medical Corporation
    FEI Number
    3011175548
    Product Code
    DYF
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    July 12, 2013
    Posted
    September 30, 2013
    Terminated
    July 15, 2014
    Address
    5 Wentworth Dr, Hudson, NH, 03051-4929

    Description

    Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

    Reason

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

    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 [email protected]

    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