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
15 of 15 products
Products covered by this recall Model / number Barcodes Product as published AG-AS3000-AU9144140519057914414061606291441407021559144140710034Lot Numbers: 9144140519057 , 9144140616062 , 9144140702155 , 9144140710034 AG-AS3000-IN91251405221169125140526101912514052707791251406090029125140609007912514061606491251406270579125140702166912514071003191251408050109125140805134Lot Numbers: 9125140522116 , 9125140526101 , 9125140527077 , 9125140609002 , 9125140609007 , 9125140616064 , 9125140627057 , 9125140702166 , 9125140710031 , 9125140805010 , 9125140805134 AG-AS3000-NE9122140520089912214052108991221405281199122140609041912214062610091221407280979122140730088Lot Numbers: 9122140520089 , 9122140521089 , 9122140528119 , 9122140609041 , 9122140626100 , 9122140728097 , 9122140730088 AG-AS3000-SC912414060901191241406200929124140623091Lot Numbers: 9124140609011 , 9124140620092 , 9124140623091 AG-AS3000-SE9123140521074912314061002391231407100339123140724097Lot Numbers: 9123140521074 , 9123140610023 , 9123140710033 , 9123140724097 AG-AS3000-UK9120140519028912014051906191201405261119120140630135912014070114491201407021569120140714044Lot Numbers: 9120140519028 , 9120140519061 , 9120140526111 , 9120140630135 , 9120140701144 , 9120140702156 , 9120140714044 AG-AS3000-US91211405210909121140522091912114052209391211405230949121140613066912114063013891211407070239121140709030Lot Numbers: 9121140521090 , 9121140522091 , 9121140522093 , 9121140523094 , 9121140613066 , 9121140630138 , 9121140707023 , 9121140709030 AG-PX1000-IN9133140704002Lot Numbers: 9133140704002 — Model Number: ; Lot Numbers AG-PX1000-NE913014052811991301406160609130140730040Lot Numbers: 9130140528119 , 9130140616060 , 9130140730040 AG-PX1000-SC91321405190729132140526107Lot Numbers: 9132140519072 , 9132140526107 AG-PX1000-SE9131140623154Lot Numbers: 9131140623154 AG-PX1000-UK912814051908191281406301359128140709024Lot Numbers: 9128140519081 , 9128140630135 , 9128140709024 AG-PX1000-US9129140527093912914061707091291407140479129140721087Lot Numbers: 9129140527093 , 9129140617070 , 9129140714047 , 9129140721087 AG-PX1000-US-Promo9129140522090912914052209191291405270939129140528095912914052809691291406160669129140617067912914061706991291406170709129140617071Lot Numbers: 9129140522090 , 9129140522091 , 9129140527093 , 9129140528095 , 9129140528096 , 9129140616066 , 9129140617067 , 9129140617069 , 9129140617070 , 9129140617071 - Amount recalled
- 1,223 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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