Device Recall Boston Scientific

Fabricante

  • Dirección del fabricante
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • 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
    USFDA

174 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    LOT 9311878, Catalogue #10142, Material #M003101420, Expires 10-JAN-2010
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA, EU, Japan, South Korea, Mexico, Colombia, and Hungary.
  • Descripción del producto
    Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm usable length, Material Number (UPN) M003101420, Catalog Number: 10142, Single-use Disposable Guide Catheters, Made in USA: 5905 Nathan Lane, Plymouth, MN 55442 USA
  • Manufacturer
  • Modelo / Serial
    LOT 9311885, Catalogue #10042, Material #H965100420, Expires 10-JAN-2010
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA, EU, Japan, South Korea, Mexico, Colombia, and Hungary.
  • Descripción del producto
    Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 90cm usable length, Material Number (UPN) H965100420, Catalog Number : 10042, Made in USA: 5905 Nathan Lane, Plymouth, MN 55442 USA
  • Manufacturer
  • Modelo / Serial
    Lot Number: 8990184
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Sweden, and South Africa.
  • Descripción del producto
    Boston Scientific Radial Jaw Large Capacity Biopsy Forceps, Sterile, 240 mm. Box of 20 || U PN Number: M00513321 || REF: 1332-20
  • Manufacturer
  • Modelo / Serial
    Lot Numbers: 8984687, 8984688, 8984689, 8990186, 9003394, 9003396, 9005718, 9005719, 9017283
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Sweden, and South Africa.
  • Descripción del producto
    Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 40 || UPN Number: M00513332 || REF: 1333-40
  • Manufacturer
  • Modelo / Serial
    Lot Number: 11712923
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    NJ, SC, TN, VA, and WI
  • Descripción del producto
    EndoVive Safety PEG Kits 20 F || Universal Product Number (UPN): MOO566460 || The product provides nutrition directly into the stomach of adult and pediatric patients who are unable to consume by conventional methods.
  • Manufacturer
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