FDAFDA · Alimentos y medicamentos·N.º oficial 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.
Publicado el 1 de julio de 2015 · Inicio del retiro: 4 de junio de 2015
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Volcano Corporation
- Distribuidor
- US Nationwide Distribution and one account in Canada.
- Lote
- Product number 9185J; lot number 50004551/005-060, serial numbers 005-060.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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