FDAJanuary 5, 2016device

Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

bard peripheral vascularbardbard peripheral

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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