FDA Devices Critical Class I Terminated

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

Reported: June 5, 2013 Initiated: April 30, 2013 #Z-1371-2013

Product Description

Reason for Recall

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

Details

Recalling Firm: Nephron Pharmaceuticals Corp.
Units Affected: 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.
Location: Orlando, FL

Frequently Asked Questions

What product was recalled? ▼

EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.. Recalled by Nephron Pharmaceuticals Corp.. Units affected: 604 each.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on June 5, 2013. Severity: Critical. Recall number: Z-1371-2013.