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Volcano Corporation recalls Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measur
Recalled July 1, 2015 · FDA recall Z-1845-2015 · Volcano
Hazard
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 · FDA Class II
Units
162 total (both devices)
Sold at
US Nationwide Distribution and one account in Canada.
Description
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
Product
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.
Manufacturer(s)
Volcano Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →