FDA-Device2016-02-17Class II
Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
Bard Peripheral Vascular Inc
Hazard
Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
Sold states
Distributed in the states of AL, TX, and CA.
Affected count
4 units
Manufactured in
1625 W 3rd St, N/A, Tempe, AZ, United States
Products
Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0786-2016Don't want to check this manually?
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