Device Recall Covidien

  • Modelo / Serial
    Lot Codes:  511851364X 512550364X 515357964X 518150364X 520150964X 523656964X 524356864X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US (nationwide) and to Canada.
  • Descripción del producto
    Covidien Dover PREC PRM 16FR SILVER FLY TY || Item Code: PP16XSD || Castile soap towelettes are used to clean the genital area for male and female patients
  • 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

76 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot Codes: 525157164X 524356164X  522957364X  522355664X  521058064X  520856764X  520159364X
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US (nationwide) and to Canada.
  • Descripción del producto
    Covidien Dover CATCH KIT SOAP || Item Code: 5205 || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • Modelo / Serial
    Lot Codes: 522959464X 525757064X
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US (nationwide) and to Canada.
  • Descripción del producto
    Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL || Item Code: 24015 || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • Modelo / Serial
    Lot Codes: 523657764X
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US (nationwide) and to Canada.
  • Descripción del producto
    Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP || Item Code: 24035 || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • Modelo / Serial
    Lot Codes: 518151164X 519450564X 520850264X 521250764X 522951064X 525150364X 525251064X
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US (nationwide) and to Canada.
  • Descripción del producto
    Covidien Dover MIDSTREAM KIT CASTILE SOAP || Item Code: 2040SA || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • Modelo / Serial
    Lot Codes: 512590564X 516087864X 517488664X 518889264X 520288264x 521689164X
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US (nationwide) and to Canada.
  • Descripción del producto
    Covidien Dover MIDSTREAM KIT CASTILE SOAP || Item Code: 2090SA || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
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