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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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-UC1000-NE; Lot Numbers: 9263140718116 , 9263140718137 , 9263140730049; 2) Model Number: AG-UC1000-UK; Lot Numbers: 9235140718022 , 9235140718093 , 9235140718154; 3) Model Number: AG-UC1500-NE; Lot Numbers: 9264140627057 , 9264140627100 , 9264140721112 , 9264140724100; 4) Model Number: AG-UC1500-SC; Lot Numbers: 9277140721040; 5) Model Number: AG-UC1500-SE; Lot Numbers: 9276140731046
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Aerogen Ltd.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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-UC1000-NE; Lot Numbers: 9263140718116 , 9263140718137 , 9263140730049; 2) Model Number: AG-UC1000-UK; Lot Numbers: 9235140718022 , 9235140718093 , 9235140718154; 3) Model Number: AG-UC1500-NE; Lot Numbers: 9264140627057 , 9264140627100 , 9264140721112 , 9264140724100; 4) Model Number: AG-UC1500-SC; Lot Numbers: 9277140721040; 5) Model Number: AG-UC1500-SE; Lot Numbers: 9276140731046
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0121-2015
Related Recalls
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.
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.
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.