BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0119-2015 · Reported October 29, 2014

    Enforcement

    Recall Number
    Z-0119-2015
    Event ID
    69236
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aerogen Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 29, 2014
    Initiation Date
    September 2, 2014
    Classification Date
    October 23, 2014
    Termination Date
    April 25, 2016
    Address
    Galway Business Park, Dangan, Galway, N/A, Ireland

    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.

    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.

    Code Info

    FRIWO AC/DC Adapter Model Number: GPP10; The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers: 1) Model Number: AG-AS3000-AU; Lot Numbers: 9144140519057 , 9144140616062 , 9144140702155 , 9144140710034; 2) Model Number: AG-AS3000-IN; Lot Numbers: 9125140522116 , 9125140526101 , 9125140527077 , 9125140609002 , 9125140609007 , 9125140616064 , 9125140627057 , 9125140702166 , 9125140710031 , 9125140805010 , 9125140805134; 3) Model Number: AG-AS3000-NE; Lot Numbers: 9122140520089 , 9122140521089 , 9122140528119 , 9122140609041 , 9122140626100 , 9122140728097 , 9122140730088; 4) Model Number: AG-AS3000-SC; Lot Numbers: 9124140609011 , 9124140620092 , 9124140623091; 5) Model Number: AG-AS3000-SE; Lot Numbers: 9123140521074 , 9123140610023 , 9123140710033 , 9123140724097; 6) Model Number: AG-AS3000-UK; Lot Numbers: 9120140519028 , 9120140519061 , 9120140526111 , 9120140630135 , 9120140701144 , 9120140702156 , 9120140714044; 7) Model Number: AG-AS3000-US; Lot Numbers: 9121140521090 , 9121140522091 , 9121140522093 , 9121140523094 , 9121140613066 , 9121140630138 , 9121140707023 , 9121140709030; 8) Model Number: AG-PX1000-IN; Lot Numbers: 9133140704002; 9) Model Number: ; Lot Numbers: ; 10) Model Number: AG-PX1000-NE; Lot Numbers: 9130140528119 , 9130140616060 , 9130140730040; 11) Model Number: AG-PX1000-SC; Lot Numbers: 9132140519072 , 9132140526107; 12) Model Number: AG-PX1000-SE; Lot Numbers: 9131140623154; 13) Model Number: AG-PX1000-UK; Lot Numbers: 9128140519081 , 9128140630135 , 9128140709024; 14) Model Number: AG-PX1000-US; Lot Numbers: 9129140527093 , 9129140617070 , 9129140714047 , 9129140721087; 15) Model Number: AG-PX1000-US-Promo; Lot Numbers: 9129140522090 , 9129140522091 , 9129140527093 , 9129140528095 , 9129140528096 , 9129140616066 , 9129140617067 , 9129140617069 , 9129140617070 , 9129140617071

    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.

    Quantity

    1,223 power adapters