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U.S. Department of Health and Human Services

Class 1 Device Recall EZ Breathe Atomizer

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 Class 1 Recall
EZ Breathe Atomizer
see related information
Date Posted May 29, 2013
Recall Status1 Open
Recall Number Z-1371-2013
Recall Event ID 65070
Product Classification Nebulizer, Medicinal, Non-Ventilatory (Atomizer) - Product Code CCQ
Product EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.
Code Information Model # EZ-100 Lots # R2029A, R2029B, R2039A, R2042A, R2045A, and R2047A. Atomizer Serial Number Ranges: 1206034476-1206069065 1207003710-1237038299 1207046505-1207081124 1208027421-1208062155 1209000001-1209069179 1209069180-1209069202 1209069203-1209069460 1210000001-1210103680 1210104001-1210104044
Recalling Firm/
Manufacturer
Nephron Pharmaceuticals Corp.
4121 SW 34th St
Orlando, Florida 32811-6475
For Additional Information Contact Jerry Webb
800-443-4313 Ext. 2292
Manufacturer Reason
for Recall
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The firm, Nephron Pharmaceuticals Corporation, notified its consignees on April 30, 2013, and May 3, 2013, of the problem via a recall notice and a Press Release, respectively. The firm directed consignees to discontinue use of any EZ Breathe atomizer units contained in the Asthmanefrin Starter Kits with the affected lot numbers and also those that were sold individually. Customers were directed to return all affected product.
Quantity in Commerce 604 each
Distribution Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AZ, CA, CO, CT, FL, IL, IN, IO, GA, KS, KY, LA, MD, MN, MS, MO, NK, NV, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN , TX, VT, VA, WA, and WV, and the countries of Guatemala, Poland, Panama, and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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