Z-1371-2013Class I

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

Name: Z-1371-2013 EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage
Creator: Nephron Pharmaceuticals Corp.
Published: 2013-04-30
License: https://open.fda.gov/license/

Nephron SC, LLC. / initiated 2013-04-30 / Terminated / root cause: manufacturing process

FDA source

Nephron Pharmaceuticals Corp. began a recall of EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage on 2013-04-30. FDA classified it as Class I and gives the reason as "Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1371-2013
Classification: Class I
Status: Terminated
Initiated: 2013-04-30
Posted: 2013-05-29
Terminated: 2016-06-28
Recalling firm: Nephron SC, LLC.
Product: EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.
Product code: CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Reason for recall: Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1371-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1371-2013	Class I	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-29
Z-1372-2013	Class I	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-29
Z-1373-2013	Class I	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-29

Product code CCQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)