Vascutek, Ltd. recalls Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace…

Recall date

May 15, 2015

Source

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

Recall number

Z-1913-2015

FDA classification

Class II

Brand / firm

Vascutek, Ltd.

Sold / distributed

Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.

Why it was recalled

Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm 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

Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.