Atrium Medical Corporation Recall 88606
Description: Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Atrium Medical Corporation Recall 88606 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2589-2021 |
| Event ID | 88606 |
| Event Description | Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of Florida and the countries of South Korea and Poland. |
| Quantity | 28 units |
| Recall Reason | The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling. |
| Device Classification | 20211006 |
| Device Code Info | Lot 458755 Serial numbers 458755001 458755007 458755013 458755019 458755025 458755002 458755008 458755014 458755020 458755026 458755003 458755009 458755015 458755021 458755027 458755004 458755010 458755016 458755022 458755028 458755005 458755011 458755017 458755023 458755029 458755006 458755012 458755018 458755024 458755030 |
| Center Classification Date | 20210929 |
| Recall Initiation Date | 20210825 |
| Recalling Firm | Atrium Medical Corporation |
| Initial Notification | Letter |
| Similar To |