Device product
EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.
Z-1371-2013
Product summary
- Event
- Event 65070
- Status
- Terminated
- Classification
- Class I
- Quantity
- 604 each
- Official record key
device-enforcement:Z-1371-2013
Official wording
Reason: Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
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
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.
Derived failure modes
-
Unknown
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.