BEUDAMED
    FDA Enforcement Class II Terminated

    I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.

    Recall: Z-1445-2013 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1445-2013
    Event ID
    64826
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    I-Flow LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 12, 2013
    Initiation Date
    June 1, 2012
    Classification Date
    June 3, 2013
    Termination Date
    June 25, 2013
    Address
    20202 Windrow Dr, N/A, Lake Forest, CA, 92630-8152, United States

    Description

    I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.

    Reason

    I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.

    Code Info

    Lot # AW207202U

    Distribution

    Nationwide distribution: USA including states of: CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI.

    Quantity

    75 units