Covidien

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

259 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot Numbers: 226543X, 230054X , 230814X, 232182X, 232805X, 234245X, 304667X,  301844X, 300446X, 305320X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.
  • Descripción del producto
    Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode || Product ID: 22550R. || Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
  • Manufacturer
  • Modelo / Serial
    Lot Numbers: 228651, 232146, 235646X, 301833X, 303928X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.
  • Descripción del producto
    Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode || Product ID: 22550P. || Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
  • Manufacturer
  • Modelo / Serial
    Lot Numbers:  13A0084N 13A0094 13B0364 13C0514
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide and the country of Bermuda
  • Descripción del producto
    Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill || Product ID: 8881570121 || Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices
  • Manufacturer
  • Modelo / Serial
    Lot Numbers:  13A0084N
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide and the country of Bermuda
  • Descripción del producto
    Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill || Product ID: 8881590123 || Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices
  • Manufacturer
  • Modelo / Serial
    Lot Numbers:  13A0084N 13D0824N
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide and the country of Bermuda
  • Descripción del producto
    Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill || Product ID: 8881590125 || Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices
  • Manufacturer
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