Imager II Angiographic Catheters


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source

3 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot: 00116127, Expiration Date: September 30, 2018
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    AZ, FL, MO, NJ, NY, OH, PA, and TX.
  • Descripción del producto
    Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Boston Scientific Imager II Angiographic Catheters
  • Manufacturer