Professional Hospital Supply,

  • Modelo / Serial
    All lot codes in the following:  Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide Foreign: Canada: Andorra Austria Belgium Czech Republic Denmark Finland France Germany Greece Ireland Israel Italy Latvia Luxembourg Monaco Netherlands Norway Poland Portugal Russian Federation Saudi Arabia Slovenia South Africa Spain Sweden Switzerland United Arab Emirates United Kingdom
  • Descripción del producto
    Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove || Item Number Description || 380789003 SURE SET SINGLE BASIN PACK || 400383006 MAJOR BASIN PACK || 400383007 MAJOR BASIN PACK || 618275004 BASIN PACK || Product Usage: || A disposable, sterile, single-use cover for compatible surgical light handles
  • 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