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 i
Check against the official notice below — it lists the full affected range.
Aerogen Ltd. is recalling 323 power adapters manufactured by FRIWO GmbH that are used with Aeroneb Solo and Pro Nebulizer systems. The company received a small number of complaints reporting that the power adapter cover had broken and separated from the adapter body before use. The affected adapters were distributed worldwide, including throughout the United States and numerous other countries.
The recalled power adapter is FRIWO Model Number GPP10, which is supplied with specific Aeroneb Nebulizer system models and lot numbers. Consumers can identify affected units by checking their device's model number and lot number against the specific combinations listed in the recall. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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, Quantity: 323 power adapters Lot/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-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 record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.