BEUDAMED
    FDA Enforcement Class I Terminated

    SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696

    Recall: Z-1210-2019 · Reported July 3, 2019

    Enforcement

    Recall Number
    Z-1210-2019
    Event ID
    82273
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2019
    Initiation Date
    February 28, 2019
    Classification Date
    June 26, 2019
    Termination Date
    July 30, 2020
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696

    Reason

    Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates.

    Code Info

    Lot Number: 18046218 Exp. Date: 04/18/2021 UDI: 50885403234352

    Distribution

    US Nationwide Distribution in the states of AR, NH, NC

    Quantity

    2900 Sets