Volcano Corporation recalls Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pr…

Recall date

June 4, 2015

Source

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

Recall number

Z-1845-2015

FDA classification

Class II

Brand / firm

Volcano Corporation

Sold / distributed

US Nationwide Distribution and one account in Canada.

Why it was recalled

During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture

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

What was recalled

Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.