Z-1371-2013 Class I Terminated

Recalled by Nephron Pharmaceuticals Corp. — Orlando, FL

Recall Details

Product Type
Devices
Report Date
June 5, 2013
Initiation Date
April 30, 2013
Termination Date
June 28, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
604 each

Product Description

EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.

Reason for Recall

Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.

Distribution Pattern

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.

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