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Class 1 (death risk) recall issued for EZ Breathe Atomizers

This week, an over-the-counter asthma-relief inhaler called the EZ Breathe Atomizer containing the medicine Asthmanefrin became the subject of a Class 1 recall by the Food and Drug Administration. In FDA parlance, a Class 1 as involving a reasonable probability of serious, adverse health effects or death if the defective medical device is used as instructed. The inhalers were also sold as "Asthmanefrin Starter Kits."

The inhalers are manufactured by Nephron Pharmaceuticals Corporation but labeled as sold under the manufacturer's brand name "Health & Life Co. Ltd." The model number is Model #EZ-100, and the boxes contained a medication cup.

Not all EZ Breathe Atomizers have been recalled. So, if you use the product, it is important to check your own atomizer against the recall list. Generally, these were manufactured between May and October of last year and sold in stores between Aug. 2012 and April of this year.

Product codes and lot numbers of the recalled atomizers are available on Nephron/Health & Life's EZ Breathe Atomizer information page. You can also call the company toll-free at 1-855-413-8920 between 8:00 a.m. to 5:00 p.m. Eastern Time to check whether your inhaler is included in the recall.

The problem is that a washer required to make the atomizer work is dangerously defective. Inhalers work by atomizing liquid medications into aerosol form so that they can be breathed into the lungs along with air. When the consumer uses the product, this washer can become dislodged and can be swallowed. This could cause a potentially fatal choking hazard, even for adults.

If you have an EZ Breather Atomizer in your home, you should stop using it immediately until you have verified whether the one you have is one of the defective devices.

Source: NewsInferno, "EZ Breathe Atomizers Recalled Over Manufacturing Defect," Cynthia A. Diaz-Shephard, June 4, 2013

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