Device Recall Kerlix" XRay Detectable Laparotomy Sponges

  • Modelo / Serial
    All lots beginning with 110000311262 through lot 15G162262X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.
  • Descripción del producto
    Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) || Item Number: 4037
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • 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

Dispositivo con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    All lots beginning with 110000142862 through lot 130002191062X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.
  • Descripción del producto
    Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x 43.2 cm) || Item Number: 4034
  • Manufacturer