BEUDAMED
    FDA Enforcement Class II Terminated

    Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic, single use, radiopaque intravascular catheter device used for the administration of medically prescribed fluids, designed to reduce the risk of accidental secondary needle sticks.

    Recall: Z-1218-2019 · Reported May 1, 2019

    Enforcement

    Recall Number
    Z-1218-2019
    Event ID
    80887
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 1, 2019
    Initiation Date
    August 22, 2018
    Classification Date
    April 25, 2019
    Termination Date
    February 11, 2021
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic, single use, radiopaque intravascular catheter device used for the administration of medically prescribed fluids, designed to reduce the risk of accidental secondary needle sticks.

    Reason

    Several lots of Jelco¿ ViaValve" safety intravenous (I.V.) catheters exhibited a V shaped puncture at the base of the catheter near the hub due to an adjustment that was made in the manufacturing process.

    Code Info

    Lot Numbers: 3584467, 3584468, 3584469, 3576073, 3576233, 3578511, 3578512

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, and New Zealand.

    Quantity

    136,600 units