Recall Class: Class I
Date Recall Initiated: April 30, 2013
Product: EZ Breathe Atomizer
Manufacturing Dates: May 2012 – October 2012
Distribution Dates: August 2012 – April 2013
Product Codes and Lot Numbers: To locate the serial numbers of the affected products, refer to the EZ Breathe Atomizer information page.
Use: The EZ Breathe Atomizer is a device that is intended to spray liquid medication in aerosol form into the air that a person will breathe.
Nephron Pharmaceuticals Corporation
4121 SW 34th St
Orlando, FL 32811
Reason for Recall: A Medical Device Recall was issued after Health & Life Co., LTD became aware of a manufacturing defect which could result in the washer ("Plate A") becoming dislodged from the EZ Breathe Atomizer. If this occurs, users may accidentally swallow the washer or choke on it, which can lead to serious adverse health consequences or death.
Nephron Pharmaceuticals Corporation is initiating this recall on behalf of Health & Life Co., LTD
Public Contact: Questions should be directed to the EZ Breathe Atomizer Recall Customer Care Center at 1-855-413-8920 from 8 am to 5 pm Eastern Time.
FDA District: Florida District Office
On April 30, 2013, Health & Life Co., LTD issued a Medical Device Recall and notified customers of the problem and products affected.
The EZ Breathe Atomizer is manufactured by Health & Life Co., LTD and sold to Nephron Pharmaceuticals Corporation. Nephron Pharmaceuticals Corporation distributes the EZ Breathe Atomizer for sale and use in the Asthmanefrin Starter Kit.
The EZ Breathe Atomizer was also sold by Nephron Pharmaceuticals Corporation as an individual device in a carton labeled EZ Breathe Atomizer, Model #EZ-100.
The EZ Breathe Atomizer includes a part called the "medication cup". The medication cup (as a replacement part) was distributed by Nephron Pharmaceuticals Corporation.
Customers should stop using any EZ Breathe Atomizer units contained in the Asthmanefrin Starter Kits with the affected lot numbers and also those that were sold individually.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.