Devices

Device Recall Oridion

Fabricante

Oridion Medical 1987 Ltd.
  • Dirección del fabricante
    Oridion Medical 1987 Ltd., 7 Hamarpe St., P.O. Box 45025, Har Hotzvim Industrial Park, Jerusalem Israel
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • 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

7 dispositivos con un nombre similar

Más información acerca de la data acá

Device Recall Oridion
  • Modelo / Serial
    Lot Numbers: M8204L10 M8357N10
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.
  • Descripción del producto
    Oridion Surestream CO2 Sampling Lines- || SureLine O2 || Part Number: 010979-03 || Product Usage: || The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.
  • Manufacturer
    Oridion Medical 1987 Ltd.
Device Recall Oridion
  • Modelo / Serial
    Lot numbers: M8210L10, M8269M10, M8446P10, M8463A11
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.
  • Descripción del producto
    Oridion Surestream CO2 Sampling Lines- || Sure VentLine Set Adult/Pediatric || Part Number: 010986-03 || Product Usage: || The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.
  • Manufacturer
    Oridion Medical 1987 Ltd.
Device Recall Oridion
  • Modelo / Serial
    Lot Numbers:  M8190L10, M8203L10, M8353N10
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.
  • Descripción del producto
    Oridion Surestream CO2 Sampling Lines- || SureLine Adult || Part Number: 010976-03 || Product Usage: || The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.
  • Manufacturer
    Oridion Medical 1987 Ltd.
Device Recall Oridion
  • Modelo / Serial
    Lot Numbers: M8209L10, M8262M10
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.
  • Descripción del producto
    Oridion Surestream CO2 Sampling Lines- || Smart SureLine Plus O2 adult || Part Number: 010981-03 || Product Usage: || The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.
  • Manufacturer
    Oridion Medical 1987 Ltd.
Device Recall Oridion
  • Modelo / Serial
    Lot Numbers: M8337N10, M8507A11, M8552B11
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.
  • Descripción del producto
    Oridion Surestream CO2 Sampling Lines- || Sure VentLine H Set Adult/Pediatric || Part Number: 010987-03 || Product Usage: || The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.
  • Manufacturer
    Oridion Medical 1987 Ltd.
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