Events

Retiro De Equipo (Recall) de Aeroneb Professional Nebulizer System

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 Aerogen 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
    69236
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0118-2015
  • Fecha de inicio del evento
    2014-09-02
  • Fecha de publicación del evento
    2014-10-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-04-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129996
  • 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
    Aerogen has received a small number of complaints in relation to the main power adapter manufactured by friwo gmbh and used in the aeroneb solo and pro nebuliser systems. the complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.
  • Acción
    URGENT FIELD SAFETY NOTICE letters dated September 2, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to: 1) compare their power adapter date codes against those found in the letter as being subject to this recall; 2) until new power adapters are received, customers may continue to use the recalled power adapters if the customer inspects each power adapter prior to use and finds that there is no evidence of damage or separation of the housing and unplug the adapter after each use; and, 3) contact the Aerogen or appropriate Aerogen sales partner immediately so that the power adapter can be replaced free of charge. The letter further requests that the recall notification be forwarded to any parties that may have received the recalled power adapters. Customers with questions can contact Aerogen at 866-423-76436.

Device

Aeroneb Professional Nebulizer System
  • Modelo / Serial
    FRIWO AC/DC Adapter Model Number: GPP10;   The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer Pro family of systems: and their respective model numbers:   1) Model Number: AG-AP1040-AU; Lot Numbers: 8003140519057 , 8003140708015 , 8003140722089 ;  2) Model Number: AG-AP1040-EU; Lot Numbers: 800140731124 , 8000140520074 , 8000140520087 , 8000140520087 , 8000140530103 , 8000140619082 , 8000140620092 , 8000140624103 , 8000140624118 , 8000140701104 , 8000140702153 , 8000140721056 , 8000140726097 , 8000140728100 , 8000140728117 , 8000140728120 , 8000140625100,  8000140624100;  3) Model Number: AG-AP1040-UK; Lot Numbers: 8001140519067 , 8001140624115 , 8001140714044 , 8001140728065 , 8001140731125;  4) Model Number: AG-AP1040-US; Lot Numbers: 8002140520090 , 8002140521088 , 8002140522091 , 8002140522093 , 8002140523094 , 8002140523095 , 8002140526114 , 8002140527096 , 8002140603121 , 8002140603130 , 8002140613067 , 8002140613068 , 8002140616069 , 8002140616070 , 8002140626123 , 8002140627124 , 8002140627125 , 8002140627138 , 8002140711036 , 8002140714042 , 8002140721085 , 8002140721087 , 8002140722091 , 8002140722092 , 8002140722093;  5) Model Number: AG-AP1500-IN; Lot Numbers: 9948140702153;  6) Model Number: AG-AP1500-UK; Lot Numbers: 9953140801132;  7) Model Number: AG-AP1500-US; Lot Numbers: 9939140522091 , 9939140630138;  8) Model Number: AG-AP6000(DG)-FR; Lot Numbers: 9998140611025;  9) Model Number: AG-AP6000(DG)-GE; Lot Numbers: 9997140611024;  10) Model Number: AG-AP6000(DG)-IN; Lot Numbers: 9996140728059;  11) Model Number: AG-AP6000-AU; Lot Numbers: 9915140722056 , 9915140722089;  12) Model Number: AG-AP6000-CH; Lot Numbers: 9966140521021 , 9966140624102;  13) Model Number: AG-AP6000-FR; Lot Numbers: 9905140521074 , 9905140526108 , 9905140610023 , 9905140731072;  14) Model Number: AG-AP6000-GE; Lot Numbers: 9904140519141 , 9904140520089 , 9904140626100 , 9904140702149 , 9904140726097;  15) Model Number: AG-AP6000-IN; Lot Numbers: 9913140520026 , 9913140526077 , 9913140526102 , 9913140603083 , 9913140609009 , 9913140617074 , 9913140624117 , 9913140703160 , 9913140703160 , 9913140703164 , 9913140704022 , 9913140709028 , 9913140709029 , 9913140711152 , 9913140721008 , 9913140721057 , 9913140721078 , 9913140728104 , 9913140728111 , 9913140801129 , 9913140805137 , 9913140604097,  9913140603097 , 9913140609129,  9913140603129,  9913140724004,  9913140725004,  9913140729004,  9913140728004,  9913140723004;  16) Model Number: AG-AP6000-IT; Lot Numbers: 9906140515023 , 9906140710033;  17) Model Number: AG-AP6000-NO; Lot Numbers: 9916140519058;  18) Model Number: AG-AP6000-RU; Lot Numbers: 9968140704166,  9968140721077;  19) Model Number: AG-AP6000-SP; Lot Numbers: 9907140519028 , 9907140730097;  20) Model Number: AG-AP6000-SW; Lot Numbers: 9927140607011;  21) Model Number: AG-AP6000-UK; Lot Numbers: 9903140520025 , 9903140526111 , 9903140722056 , 9903140728098;  22) Model Number: AG-AP6000-US; Lot Numbers: 9902140616065 , 9902140616067 , 9902140617070
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of CA, GA, IL, MS, NC, and TX, and the countries of Australia, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, Norway, Poland, Qatar, Russia, South Korea, Singapore, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
  • Descripción del producto
    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. || The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. || The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
  • Manufacturer
    Aerogen Ltd.

Manufacturer

Aerogen Ltd.
  • Dirección del fabricante
    Aerogen Ltd., Galway Business Park, Dangan, Galway Ireland
  • Empresa matriz del fabricante (2017)
    Aerogen Ltd.
  • Source
    USFDA