FDA Device recall Z-2312-2013
Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access
- FDA Device
- Class II
- terminated
- Published 2013-10-09
On 2013-10-09 the FDA classified a Class II recall of Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access by Atrium Medical, citing inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2312-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-12 |
| Published | 2013-10-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Atrium Medical |
| Distribution | US |
Product
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
Identifiers
| 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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2312-2013%22
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