Device product
Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
Z-0786-2016
Product summary
- Event
- Event 73022
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-0786-2016
Official wording
Reason: Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
Code information: Product Code: DF8006SC Lot Number: VTZE1783
Distribution pattern: Distributed in the states of AL, TX, and CA.
Derived failure modes
-
Labeling or packaging
mislabeling