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 the main power adapter manufactured by FRIWO GmbH used in Aeroneb Solo and Pro Nebulizer systems due to a small number of complaints that the power adapter cover broke and dislodged from the adapter body prior to use. The recall affects 36 power adapters distributed worldwide, including throughout the United States and numerous other countries. The affected adapters are FRIWO Model Number GPP10 supplied with specific Aeroneb Nebulizer system models and lot numbers.
The recall notice does not specify a remedy or what affected consumers should do.
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: 36 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: 1079422; Lot Numbers: 9070140620088 , 9070140723088 , 9070140723088; 2) Model Number: 1082693; Lot Numbers: 9073140618134; 3) Model Number: 1082694; Lot Numbers: 9074140530079
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.