Drug recall
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is…
FDA recall event 69236 · Class II · Aerogen Ltd.
Key facts
| Event ID | 69236 |
|---|---|
| Recall numbers | Z-0118-2015, Z-0119-2015, Z-0120-2015, Z-0121-2015 |
| Recalling firm | Aerogen Ltd. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Sep 2, 2014 |
| Report date | Oct 29, 2014 |
| Termination date | Apr 25, 2016 |
| City | Galway |
| Country | Ireland |
| FEI number | 3003399703 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: