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U.S. Department of Health and Human Services

Class 2 Device Recall Aeroneb Professional Nebulizer System

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  Class 2 Device Recall Aeroneb Professional Nebulizer System see related information
Date Initiated by Firm September 02, 2014
Date Posted October 23, 2014
Recall Status1 Terminated 3 on April 25, 2016
Recall Number Z-0119-2015
Recall Event ID 69236
510(K)Number K021175  
Product Classification Nebulizer (direct patient interface) - Product Code CAF
Product 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.
Code Information 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
Recalling Firm/
Manufacturer		 Aerogen Ltd.
Galway Business Park
Dangan
Galway Ireland
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action URGENT 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 partner immediately so that the power adapter can be replaced free of charge. The letter further requests that the recall notification be forwarded to any parties that may have received the recalled power adapters. Customers with questions can contact Aerogen at 866-423-76436.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CAF and Original Applicant = AEROGEN, INC.
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