The Aeroneb Professional Nebulizer System is a portable recall
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed…
Why was The Aeroneb Professional Nebulizer System is a portable recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed…
- Recalling firm
- Aerogen Ltd.
- Quantity
- 1,223 power adapters
- 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.
- Recall date
- October 29, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)