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08-10-2013, 06:25 PM #1
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Health & Life Co., LTD. Issues Nationwide Recall of EZ Breathe™ Atomizer, Model EZ100
Asthmanefrin™ In the News
Important EZ Breathe Atomizer Information
By Asthmanefrin | Published: May 9, 2013
IMPORTANT MEDICAL DEVICE CORRECTION:
Health and Life Co., LTD. has initiated a voluntary nationwide recall to the user level for the EZ Breathe Atomizer after becoming aware of an increase in the number of complaints. These manufacturing performance issues have been addressed and the device has been revised accordingly.
For more information, please see the notice below.
Medical Device Recall News Release
Health & Life Co., LTD. Issues Nationwide Recall of EZ Breathe™ Atomizer, Model #EZ-100
FOR IMMEDIATE RELEASE: May 8, 2013
Recall Managed By: Nephron Pharmaceuticals Corporation
Health & Life Co., LTD
9F, No. 186, Jian Yi Road
Zhonge District 23553
New Taipei City, Taiwan
On May 8, 2013, Health & Life, Co., LTD, initiated a nationwide recall of 242,892 EZ Breathe™ Atomizers, Model #EZ-100, after becoming aware of an increase in the number of complaints. The Atomizers have been determined to have the possibility of a manufacturing defect which results in a quarter-inch diameter washer becoming dislodged from the EZ Breathe™ Atomizer, which potentially could result in a choking hazard. This product is manufactured by Health & Life Co., LTD. in Taiwan for Nephron Pharmaceuticals Corp., who is managing the recall activities. No injuries have been reported to date.
The EZ Breathe™Atomizer can be found in these three presentations:
1) Packaged in the Asthmanefrin® Starter Kit, NDC 0487-2784-10. Each Asthmanefrin® Starter Kit contains 10 vials of Asthmanefrin® medication that are manufactured by Nephron Pharmaceuticals Corp. and one EZ Breathe™ Atomizer.
Affected Asthmanefrin® Starter Kit Lot #’s: R2029A, R2029B, R2039A, R2042A, R2045A, and R2047A.
2) EZ Breathe™ Atomizers Model # 100
Affected Atomizer Serial Number Ranges:
1206034476 – 1206069065
1209069180 – 1209069202
1207003710 – 1207038299
1209069203 – 1209069460
1207046505 – 1207081124
1210000001 – 1210103680
1208027421 – 1208062155
1210104001 – 1210104044
1209000001 – 1209069179
Serial numbers can be identified on the battery door of the atomizer
3) Replacement Medication Cup
Affected Lot #’s: 120902, 120903 and 120904
(lot numbers are found on the medication cup packaging)
Recalled EZ Breathe™ Atomizers were manufactured from May 21, 2012 through October 29, 2012 and distributed from August 3, 2012 through April 24, 2013.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Nephron Pharmaceuticals Corp. is notifying its distributors and customers by either direct mail, email or telephone and is arranging for the return of all recalled Atomizers. Nephron Pharmaceuticals Corp. distributed EZ Breathe™ Atomizers contained in Asthmanefrin® Starter Kits nationwide to drug wholesalers, pharmacies and individuals.
Consumers who have affected EZ Breathe™ Atomizers (as referenced above) should stop using, and contact the EZ Breathe Atomizer Recall Customer Care Center at 1-855-413-8920, between the hours of 8:00 am and 5:00pm EDT, for return and replacement of their EZ Breathe™ Atomizer at no charge.