EZ Breathe Atomizer Recall Issued Due to Choking Hazard

Nearly a quarter of a million EZ Breathe Atomizers have been recalled, due to the risk that a small washer in the device may become dislodged during use and potentially cause patients to choke.  

The EZ Breathe Atomizer recall was issued after the manufacturer, Life & Health Co., identified that a quarter inch washer on “Plate A” may come loose and cause life threatening risks for users. The problems may affect 242,892 atomizers.

The FDA has classified the action as a Class I medical device recall, suggesting that continued use of the device may pose a substantial risk of severe injury or death.

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The EZ Breathe Atomizer is used by patients to spray liquid medication into aerosol form so that they may breathe in the medication. This type of treatment is commonly used to widen airways and provide temporary relief of shortness of breath, chest tightness, and wheezing.

The recall consists of EZ Breathe Atomizer’s Model #EZ-100 including the starter kits and replacement medication cups. The recalled Asthmanefrin Starter Kits have NDC number 0487-2784-10 and have Lot numbers R2029A, R2029B, R2039A, R2042A, R2045A, and R2047A. The affected EZ-100 models have serial numbers located on the battery door of the Atomizer’s ranging from 1206034476 – 1206069065, 1207003710 – 1207038299, 1207046505 – 1207081124, 1208027421 – 1208062155, 1209000001 – 1209069179, 1209069180 – 1209069202, 1209069203 – 1209069460, 1210000001 – 1210103680, and 1210104001 – 1210104044. The affected replacement medication cups have the following affected Lot numbers; 120902, 120903, and 120904.

The Atomizer’s were manufactured by Health & Life Co. and sold to Nephron Pharmaceuticals Corporation of Orlando, Florida and where they were sold nationwide to drug wholesalers, pharmacies and to individuals from August 2012 through April 2013.

The FDA has recommended that consumers stop using the recalled Atomizer’s and contact EZ Breath Atomizer Recall Customer Care Center at 1-855-413-8920 during normal business hours to return and replace the product free of charge.

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