FDAFDA · Food and drugs·Recall number Z-2316-2013
Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Published October 9, 2013 · Recall initiated: July 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Atrium Medical Corporation
- Distributor
- 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
- Lot
- Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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