Z-0121-2015Class II

The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is...

Name: Z-0121-2015 The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is...
Creator: Aerogen Ltd.
Published: 2014-09-02
License: https://open.fda.gov/license/

Aerogen Ltd. / initiated 2014-09-02 / Terminated / root cause: manufacturing process

FDA source

Aerogen Ltd. began a recall of The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions... on 2014-09-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0121-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-02
Posted: 2014-10-23
Terminated: 2016-04-25
Recalling firm: Aerogen Ltd.
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.
Product code: CAF Nebulizer (Direct Patient Interface)
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.
Root cause tag: manufacturing process
FDA root cause: 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: 323 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.
Product codes and lots: 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-UC1000-NE; Lot Numbers: 9263140718116 , 9263140718137 , 9263140730049; 2) Model Number: AG-UC1000-UK; Lot Numbers: 9235140718022 , 9235140718093 , 9235140718154; 3) Model Number: AG-UC1500-NE; Lot Numbers: 9264140627057 , 9264140627100 , 9264140721112 , 9264140724100; 4) Model Number: AG-UC1500-SC; Lot Numbers: 9277140721040; 5) Model Number: AG-UC1500-SE; Lot Numbers: 9276140731046

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0121-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0118-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-23
Z-0119-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-23
Z-0120-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-23
Z-0121-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-23

Product code CAF

K021175Class IIAeroneb Professional Nebulizer System, Model#ag-Ap6000Aerogen, Inc. / cleared 2002-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)