Covidien, LLC

¿Qué es esto?

Description

  • Dirección del fabricante
    Covidien, LLC, 540 Oakmead Pkwy, Sunnyvale CA 94085-4022
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA
  • 2 Event

2 dispositivos en la base de datos

  • Modelo / Serial
    Item Code: CYTO-101-01. Lot numbers: F2500566X, F2500628X, F2500202X, F2500351X.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.
  • Descripción del producto
    Covidien Cytosponge Cell Collection Device. || Item code CYTO-101-01. || Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies.
  • Modelo / Serial
    Item Code: CYTO-KIT-R; Lot numbers: 3441120915, 3441102015
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.
  • Descripción del producto
    Covidien Cytosponge Cell Collection Kit. || Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. || Item code CYTO-KIT-R || Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Currently the device is only available for clinical studies.