Recalls

Asthma drug delivery system recalled due to life-threatening manufacturing defect

fda logo Asthma drug delivery system recalled due to life threatening manufacturing defectNephron Pharmaceuticals Corp. EZ Breathe Atomizer, a device used to spray liquid medication in aerosol for into the air that a person breathes, is being recalled because of a manufacturing defect that could result in a washer becoming dislodged from the device. If this occurs, users may accidentally swallow the washer or choke on it, which could cause serious health consequences or death.

The EZ Breathe Atomizer is sold to individuals who require the device to deliver medications, such as asthma drugs. It is for sale and use in the Asthmanefrin Starter Kit, and is also sold as an individual device in a carton labeled EZ Breathe, Model #EZ-100. The affected devices were manufactured between May 2012 and October 2012, and distributed between August 2012 and April 2013.

Affected models can be found here: http://www.asthmanefrin.com/blog. Customers with affected devices should contact the EZ Breathe Atomizer Recall Customer Care Center at 1-855-413-8920 between 8 a.m. to 5 p.m. Eastern Time.

This recall is listed as a Class 1. Recalls in this class involves situations in which there is a reasonable probability the products will cause serious adverse health consequences or death.

Any side effects or quality problems with this or any other medical device should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA