A Medical Device Recall was issued due to a manufacturing defect which could result in the washer becoming dislodged from the EZ Breathe Atomizer. If this occurs, users may accidentally swallow the washer or choke on it.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
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. Devices were distributed between August 2012 and April 2013.
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.
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.
The units come in three forms:
- Packaged in the Asthmanefrin Starter Kit, NDC 0487-2784-10
- EZ Breathe Atomizers Model # 100
- Replacement Medication Cup
See the FDA Safety Alert
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication.