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Vascutek, Ltd. recalls Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, repla
Recalled July 8, 2015 · FDA recall Z-1912-2015 · Vascutek
Hazard
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft. · FDA Class II
Units
12
Sold at
Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
Description
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Product
Gelseal Straight Diameter 8mm Length 15cm. 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.
Manufacturer(s)
Vascutek, Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →