Device Recall Monoject Prefill 100UlmL Heparin

Fabricante

  • Dirección del fabricante
    Covidien LP, 15 Hampshire St, Mansfield MA 02048-1113
  • 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
    Lot Numbers: 7041194; 7102804; 7041204; 7113034; 7051534; 7113044; 7051544; 7113054; 7051554 ; 7113104; 7071924 ; 7113114; 7072034; 7113154; 7072044;  8010064; 7072054; 8010114; 7072064 ; 8010134; 7072154;  8010174; 7082284;
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Tyco Healthcare Monoject Prefill100U/mL Heparin || Lock Flush Syringe 5mL || REF # 8881590125, Tyco Healthcare, Mansfield, MA 02048
  • Manufacturer