FDAFDA · Alimentos y medicamentos·N.º oficial Z-2302-2013
NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 The NC Sprinter Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The balloon at the distal end of the catheter can be inflated to a defined diameter at a specific pressure (see labelling). The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter provides a lumen which enables the use of a guide wire to position the catheter. Radiopaque balloon marker(s) enable accurate placement. Shaft markers for brachial and femoral techniques are in place.
Publicado el 9 de octubre de 2013 · Inicio del retiro: 16 de septiembre de 2013
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
Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the size of the device as 2.5mm instead of the correct 2.25mm size.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Medtronic Vascular, Inc.
- Distribuidor
- Worldwide Distribution - USA and the countries of Australia, Belgium, Canada, Hong Kong, Malaysia, New Zealand, Singapore, Spain, Switzerland, Taiwan and Thailand.
- Lote
- Lot number 207002011; Exp 5-13-2015.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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