Bard Distaflo Vascular Bypass Graft recalled over labeling errors

Recall date

January 5, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Bard Peripheral Vascular Inc recalls Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of per…

Recall number

Z-0786-2016

FDA classification

Class II

Brand / firm

Bard Peripheral Vascular Inc

Sold / distributed

Distributed in the states of AL, TX, and CA.

Why it was recalled

Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.