Device product
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Z-0289-2026
Product summary
- Event
- Event 97700
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0289-2026
Official wording
Reason: The device was incorrectly packed in the wrong size labeled outer packaging.
Code information: REF: AG1015; UDI-DI: 00316837000343; Lot/Serial Number: 23MM581-016;
Distribution pattern: US distribution to the state of: AR
Derived failure modes
-
Unknown
The device was incorrectly packed in the wrong size labeled outer packaging.