BEUDAMED
    FDA Enforcement Class II Terminated

    ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.

    Recall: Z-1969-2019 · Reported July 24, 2019

    Enforcement

    Recall Number
    Z-1969-2019
    Event ID
    83213
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pharmaceutical Innovations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 24, 2019
    Initiation Date
    June 19, 2019
    Classification Date
    July 12, 2019
    Termination Date
    July 29, 2020
    Address
    897 Frelinghuysen Ave, N/A, Newark, NJ, 07114-2122, United States

    Description

    ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.

    Reason

    Potential for failed stability antimicrobial effectiveness testing.

    Code Info

    Lot # 060714-25, 080614-25, 101515-25, 070116-25, 072816-25A, 072816-25, 021317-25, 010118-25,102018-25.

    Distribution

    US nationwide distribution including the states of AZ, CA, CT, FL, IL, MA, MI, MN, NC, NJ, NY, OH, PA, RI, TX, TN, VT, WV. Distributed Internationally to accounts in Australia, France, Germany, Hong Kong, Saudi Arabia and Canada.

    Quantity

    71653