Reported Oct 29, 2014 · Terminated
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to…
Aerogen Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aerogen Ltd. · Galway Business Park · Galway · N/A
Is this the product you have?
- 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.
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Barcodes Product as published AG-UC1000-NE926314071811692631407181379263140730049Lot Numbers: 9263140718116 , 9263140718137 , 9263140730049 AG-UC1000-UK923514071802292351407180939235140718154Lot Numbers: 9235140718022 , 9235140718093 , 9235140718154 AG-UC1500-NE9264140627057926414062710092641407211129264140724100Lot Numbers: 9264140627057 , 9264140627100 , 9264140721112 , 9264140724100 AG-UC1500-SC9277140721040Lot Numbers: 9277140721040 AG-UC1500-SE9276140731046Lot Numbers: 9276140731046 - Amount recalled
- 323 power adapters
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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