Nephron Pharmaceuticals announced a medical device recall due to a manufacturing defect found in the EZ Breathe Atomizer. The defect could result in the washer (Plate A) dislodging from the EZ Breathe Atomizer, which a patient can accidentally choke on or swallow. The patient may experience serious health consequences or even death if this occurs.
The EZ Breathe Atomizer is a medical device designed to spray liquid medication in aerosol form into the air that a person inhales.
The affected devices have Model #EZ-100 and were distributed between August 2012–April 2013. The EZ Breathe Atomizer can be found as part of the Asthmanefrin (racepinephrine 2.25% inhalation solution; Nephron) Starter Kit or sold individually in unit containers. The full list of affected lot and serial numbers can be found on the Asthmanefrin Blog.
Patients are to stop using any of the affected EZ Breathe Atomizer units contained in the Asthmanefrin Starter Kits in addition to those sold individually.
For more information call (855) 413-8920 or visit the FDA website.