FDAFDA · Alimentos y medicamentos·N.º oficial Z-0055-2017
Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a working length of 135cm and is compatible with various guidewire diameters. Model 5200 also has hydrophilic coating on the distal 18cm of the catheter. The Twin-Pass catheter has white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively. The Twin-Pass catheter has a marker band located 1mm from the distal tip. Model 5200 contains a second marker band located 11mm from the distal tip to identify the distal end of the OTW lumen.
Publicado el 26 de octubre de 2016 · Inicio del retiro: 16 de septiembre de 2016
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
Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Vascular Solutions, Inc.
- Distribuidor
- Worldwide Distribution: US (nationwide) including Puerto Rico and outside the US to include: Australia, Austria, Belgium, Brazil, Canada, Cyprus, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.
- Lote
- Model 5230, Lot numbers: 577279, 578997, 580613, 583021, 584463, 586310, 588542, 590739, 591262, 593696, 593985.
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.