Imager II Angiographic Catheter

Fabricante

  • 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
    DHTGA

14 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
    2
  • ¿Implante?
    No
  • 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
    Lot: 00112758, Use by 2018-05-11
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    CA, FL, KY, MO, NM, OK, OR, PA, and TX.
  • Descripción del producto
    Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
  • Manufacturer
  • Modelo / Serial
    Multiple Lot numbers of the affected device are provided in the attached FSN.
  • Descripción del producto
    Catheter
  • Manufacturer
9 más