BEUDAMED
    FDA Enforcement Class II Terminated

    T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.

    Recall: Z-0796-2016 · Reported February 17, 2016

    Enforcement

    Recall Number
    Z-0796-2016
    Event ID
    73130
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Salter Labs
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 17, 2016
    Initiation Date
    January 5, 2016
    Classification Date
    February 10, 2016
    Termination Date
    April 21, 2016
    Address
    2365 Camino Vida Roble, N/A, Carlsbad, CA, 92011-1505, United States

    Description

    T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.

    Reason

    Reports that the T-piece does not fit on the nebulizer.

    Code Info

    Lot No. 083115, 090715, and 122815

    Distribution

    Distributed in the states of TX, NY, PA, TN, SC, and OH, and in China.

    Quantity

    70 units