FDAFDA · Food and drugs·Recall number Z-1845-2015
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.
Published July 1, 2015 · Recall initiated: June 4, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Volcano Corporation
- Distributor
- US Nationwide Distribution and one account in Canada.
- Lot
- Product number 9185J; lot number 50004551/005-060, serial numbers 005-060.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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