BEUDAMED
    FDA Enforcement Class II Terminated

    ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.

    Recall: Z-1146-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1146-2018
    Event ID
    79324
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vascular Insights, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 28, 2018
    Initiation Date
    November 9, 2017
    Classification Date
    March 20, 2018
    Termination Date
    December 18, 2018
    Address
    1 Pine Hill Dr Ste 100, N/A, Quincy, MA, 02169-7485, United States

    Description

    ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.

    Reason

    Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction of the catheter into a vascular access introducer.

    Code Info

    Lot number: BM651403017I

    Distribution

    U.S Nationwide in the states: AZ, CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MO, NE, NJ, NY, OH, PA, SC, TN, TX, VA, WA

    Quantity

    928