Events

Recall of Aeroneb Professional Nebulizer System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aerogen Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69236
  • Event Risk Class
    Class 2
  • Event Number
    Z-0118-2015
  • Event Initiated Date
    2014-09-02
  • Event Date Posted
    2014-10-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129996
  • Notes / Alerts
    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.
  • Extra notes in the data
    Nebulizer (direct patient interface) - Product Code CAF
  • Reason
    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.
  • Action
    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
  • Model / 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
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer Address
    Aerogen Ltd., Galway Business Park, Dangan, Galway Ireland
  • Manufacturer Parent Company (2017)
    Aerogen Ltd.
  • Source
    USFDA