Device product
Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
Z-0785-2016
Product summary
- Event
- Event 73022
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-0785-2016
Official wording
Reason: Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
Code information: Product Code: DF6006SC Lot Number: VTZE1782
Distribution pattern: Distributed in the states of AL, TX, and CA.
Derived failure modes
-
Labeling or packaging
mislabeling