FDAFDA · Food and drugs·Recall number Z-1371-2013
EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.
Published June 5, 2013 · Recall initiated: April 30, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nephron Pharmaceuticals Corp.
- Distributor
- 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
- 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
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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