BEUDAMED
    FDA Enforcement Class II Terminated

    Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.

    Recall: Z-1730-2015 · Reported June 17, 2015

    Enforcement

    Recall Number
    Z-1730-2015
    Event ID
    71142
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical Asd Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2015
    Initiation Date
    May 4, 2015
    Classification Date
    June 8, 2015
    Termination Date
    January 20, 2016
    Address
    6250 Shier Rings Rd, N/A, Dublin, OH, 43016-1270, United States

    Description

    Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.

    Reason

    Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the production of 1 lot of product.

    Code Info

    Product Reorder Number: 537235C; Lot #2761409

    Distribution

    Distributed to the states of KY, MN, NJ, UT, & WI.

    Quantity

    6,000 units