PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 1, 2015 Initiated: June 4, 2015 #Z-1845-2015

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Volcano Corporation
Units Affected
162 total (both devices)
Distribution
US Nationwide Distribution and one account in Canada.
Location
Rancho Cordova, CA

Frequently Asked Questions

What product 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.. Recalled by Volcano Corporation. Units affected: 162 total (both devices).
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 1, 2015. Severity: Moderate. Recall number: Z-1845-2015.

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