Device product
Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Z-2308-2013
Product summary
- Event
- Event 65697
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2308-2013
Official wording
Reason: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
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
Derived failure modes
-
Unknown
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field