BEUDAMED
    FDA Enforcement Class I Terminated

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

    Recall: Z-1372-2013 · Reported June 5, 2013

    Enforcement

    Recall Number
    Z-1372-2013
    Event ID
    65070
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nephron Pharmaceuticals Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2013
    Initiation Date
    April 30, 2013
    Classification Date
    May 29, 2013
    Termination Date
    June 28, 2016
    Address
    4121 SW 34th St, N/A, Orlando, FL, 32811-6475, United States

    Description

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

    Reason

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

    Code Info

    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

    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.

    Quantity

    241,538 kits