Atrium Medical Corporation: Medical Device Recall in 2013 - (Recall #: Z-2305-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 12, 2013

Date Posted: October 9, 2013

Recall Number: Z-2305-2013

Event ID: 65697

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

Status: Terminated

Product Quantity:

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.

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

Voluntary or Mandated:

Voluntary: Firm initiated