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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Event Detail

Event ID 65070
Product Type Devices
Status Ongoing
Recalling Firm Nephron Pharmaceuticals Corp.
City Orlando
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-30
Initial Firm Notification of
Consignee or Public
Letter
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage. 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 Class I Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. 604 each Z-1371-2013
Asthmanefrin Starter Kit contains ten (10) Asthmanefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage. 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 Class I Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. 241,538 kits Z-1372-2013
EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage. Lots #120902, Lot # 120903 and Lot # 120904 Class I Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. 750 Medications Cups Z-1373-2013
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