Important Safety Alerts

The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning EZ Breathe Atomizer, manufactured by Health & Life Co. Ltd. and distributed by Nephron Pharmaceuticals Corporation. The EZ Breathe Atomizer can be found in these three presentations:

1. Packaged in the Asthmanefrin Starter Kit, NDC 0487-2784-10
2. EZ Breathe Atomizers Model # 100+
3. Replacement Medication Cup

The affected serial/lot numbers are as follows:

1. R2029A, R2029B, R2039A, R2042A, R2045A, and R2047A
2. 1206034476 – 1206069065, 1209069180 – 1209069202, 1207003710 – 1207038299, 1209069203 – 1209069460, 1207046505 – 1207081124, 1210000001 – 1210103680, 1208027421 – 1208062155, 1210104001 – 1210104044, 1209000001 – 1209069179
3. 120902, 120903 and 120904

According to the FDA, 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.

The manufacturer has notified customers of the problem and products affected. 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.

For details, please visit the following FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm355037.htm
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm355016.htm

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 04 June 2013