Events

Retiro De Equipo (Recall) de Device Recall Microstream O2/CO2 NASAL FILTERLINE ADULT

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Oridion Medical 1987 Ltd..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    55790
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2014-2010
  • Fecha de inicio del evento
    2010-05-26
  • Fecha de publicación del evento
    2010-07-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91926
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code cck
  • Causa
    The microstream filterline may not be recognized by the monitor when connected. no co2 readings will be displayed and no alarms may sound for unmonitored patients. replacing the filterline may delay treatment.
  • Acción
    Oridion notified customers by letter on 5/26/10 and requested that they remove the FilterLines from the related production lots from the field and an immediate replacement with FilterLines from subsequent production lots. Questions are directed to the responsible person at the supplier named in the letter, or to Oridion Capnography at 888-674-3466.

Device

Device Recall Microstream O2/CO2 NASAL FILTERLINE ADULT
  • Modelo / Serial
    Lot numbers from Q0901006 to Q0908223. Produced between January and July 2009,
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AZ, CA, FL, HI, LA, , MA, MO, NJ, OH, PA, WA, WI,
  • Descripción del producto
    Microstream O2/CO2 NASAL FILTERLINE ADULT LONG O2 CONN 100UN || Part Number: 010343 || 010341 || Part Number: 10341
  • Manufacturer
    Oridion Medical 1987 Ltd.

Manufacturer

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