EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.
This recall has been terminated (originally issued May 29, 2013).
- Company
- Nephron Pharmaceuticals Corp.
- Recall Initiated
- April 30, 2013
- Posted
- May 29, 2013
- Terminated
- June 28, 2016
- Recall Number
- Z-1371-2013
- Quantity
- 604 each
- Firm Location
- Orlando, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
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.
Lot / Code Info
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
Root Cause
Nonconforming Material/Component
Action Taken
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.