The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aero

FDA device recall Z-0118-2015 · posted 2014-10-23 · Terminated

Recall details

Recalling firm

Aerogen Ltd.

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CAF

Quantity affected

2,421 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, Ger

Date initiated

2014-09-02

Date posted

2014-10-23

Date terminated

2016-04-25

Location

Dangan Galway, Ireland

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