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Recall Observatory FDA recall evidence

Device product

AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage.

Z-1372-2013

April 30, 2013

Class I

Product summary

Firm
Nephron Pharmaceuticals Corp.
Event
Event 65070
Status
Terminated
Classification
Class I
Quantity
241,538 kits
Official record key
device-enforcement:Z-1372-2013

Official wording

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

Code information: 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

    reason.no_named_rule · v1.0.0

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