FDA Medical Device Recalls (openFDA)
Nephron Pharmaceuticals Corp.: EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.
- Recall number
- Z-1371-2013
- Recalling firm
- Nephron Pharmaceuticals Corp.
- Product
- EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.
- Status
- Terminated
- Initiated
- 2013-04-30
- Posted
- 2013-05-29
- Terminated
- 2016-06-28
- Reason
- Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CCQ
- Firm FEI
- 3010892830
- Firm city
- Orlando
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28