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Nephron Pharmaceuticals Corp. EZ Breathe Atomizer: Class 1 Recall - Washer Could Become Dislodged
AUDIENCE: Consumer, Patient, Nursing, Pharmacy, Risk Managers
ISSUE: A Medical Device Recall was issued due to 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.
BACKGROUND: 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.
RECOMMENDATION: 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. Refer to the Recall Notice for a link to the affected lot and serial numbers.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the recall notice, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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