FDA-Device2015-07-08Class II
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.
Vascutek, Ltd.
Hazard
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Sold states
Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
Affected count
12
Manufactured in
Newmains Avenue, Inchinnan, United Kingdom
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1912-2015Don't want to check this manually?
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