Recall Z-2312-2013 ยท DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Atrium Medical Corporation
Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
| Date | Sep 30, 2013 (initiated Jul 12, 2013) |
| Status | Terminated |
| Reason | Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field |
| Root cause | Package design/selection |
| Action | Atrium Medical Corporation issued an Urgent Medical Device Safety Alert letter on July 16, 2013, via UPS to customers and e-mail to the field representatives that represent these accounts. The notification identifies the problem, product, and risk factors. In addition, it provides instructions how to handle product that may be affected. For questions customers were instructed to contact their Atrium Medical Customer Service at 603-880-1433 Prompt 1 or by e-mail at returns@atriummed.com |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000504 | ADVANTA SUPER SOFT GRAFT Atrium Medical Corp., Mar 1, 2000 |