Events

Retiro De Equipo (Recall) de Aeroneb Go

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 Medical Industries America Inc.

¿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
    30068
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0177-05
  • Fecha de inicio del evento
    2004-09-07
  • Fecha de publicación del evento
    2004-11-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-08-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35110
  • 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 was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Nebulizer (Direct Patient Interface) - Product Code CAF
  • Causa
    The nebulizer can either fail or provide a low flow (partial dose) of medication.
  • Acción
    The recalling firm initiated their action via telephone on 9/7/04 to the care providers to inform them of the product problem and that they would soon be receiving additional information about the recall. Between 9/24-28/04, the firm issued letters to their care providers with specific instructions as to how to decide what individuals would or would not need a backup generator in their possession. They were also instructed to pass the information onto the end user. On 10/1/04, the firm called the care providers and subsequently issued second letters or postcards to them to correct the toll free number that had been misprinted on the literature and letter.

Device

Aeroneb Go
  • Modelo / Serial
    040120, 040127, 040129, 040130, 040201, 040202, 040203, 040205, 040209, 040210, 040216, 040219, 040227, 040301, 040303, 040305, 040311, 040317, 040406, 040407, 040415, 040427, 040421, 040428, 040506, 040721, 040723, 040726, 040730, 080504, 080904, 081104, 081604, 081704, 081904, 082004, 082304, 082504, 082704, 083004, 083104, 080304
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution was made to home health care providers and pharmacies nationwide. Foreign distribution was made to Italy, Greece, France, Poland, Japan, Hong Kong, Argentina, Australia, Israel, and Singapore.
  • Descripción del producto
    Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold individually or in master packs of 8 under the following model numbers (all using the same box label): || Model 7000 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; || Model 7030 - Consisting of the Aeroneb Go, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; || Model 7070 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; || Model 7000-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, European mask elbow, mouthpiece, carry bag, and user manual; || Model 7030-1 - Consisting of the Aeroneb Go, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual; || Model 7070-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual. || 7000LINCARE - Consisting of the Aeroneb Go, battery controller with a Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; || 7070LINCARE - Consisting of the Aeroneb Go, battery controller with the Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual.
  • Manufacturer
    Medical Industries America Inc

Manufacturer

Medical Industries America Inc
  • Dirección del fabricante
    Medical Industries America Inc, 2636 289th Pl, Adel IA 50003-8021
  • Source
    USFDA