BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2312-2013 · Reported October 9, 2013

    Enforcement

    Recall Number
    Z-2312-2013
    Event ID
    65697
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Atrium Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2013
    Initiation Date
    July 12, 2013
    Classification Date
    September 30, 2013
    Termination Date
    July 15, 2014
    Address
    5 Wentworth Dr, Hudson, NH, 03051-4929, United States

    Description

    Advanta SuperSoft 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

    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.

    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