ClearanceBrief
Recall Z-0120-2015 ยท CAF Nebulizer (Direct Patient Interface)

Aerogen Ltd.

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 iterat

DateOct 23, 2014 (initiated Sep 2, 2014)
StatusTerminated
ReasonAerogen 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.
Root causeNonconforming Material/Component
ActionURGENT FIELD SAFETY NOTICE letters dated September 2, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to: 1) compare their power adapter date codes against those found in the letter as being subject to this recall; 2) until new power adapters are received, customers may continue to use the recalled power adapters if the customer inspects each power adapter prior to use and finds that there is no evidence of damage or separation of the housing and unplug the adapter after each use; and, 3) contact the Aerogen or appropriate Aerogen sales partne
Quantity36 power adapters
DistributionWorldwide 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,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K021175AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000
Aerogen, Inc., May 15, 2002