BEUDAMED
    FDA Enforcement Class II Terminated

    Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Catalog Identifiers: C-UTLMY-501J-ABRM-HC-FST and C-UTLMY-501J-ABRM-HC-IHI-FST Usage: The Spectrum Central Venous Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents, and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring

    Recall: Z-0634-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0634-2018
    Event ID
    79050
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 21, 2018
    Initiation Date
    July 31, 2017
    Classification Date
    February 15, 2018
    Termination Date
    May 8, 2019
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120, United States

    Description

    Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Catalog Identifiers: C-UTLMY-501J-ABRM-HC-FST and C-UTLMY-501J-ABRM-HC-IHI-FST Usage: The Spectrum Central Venous Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents, and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring

    Reason

    Central venous catheters may not fit over guide wire potentially causing procedure delay.

    Code Info

    Lot Number (Expiration date): 7693203 (01-May-2019), 7611811 (01-May-2019), 7625110 (01-May-2019), 7625111 (01-May-2019), 7689802 (01-May-2019), 7713113 (01-May-2019), and 7724842 (01-September-2019),

    Distribution

    Worldwide distribution - US Nationwide in the states of: AL, CA, CO, FL, GA, IA, IL, KY, LA, MD, MI, MN, MO, NC, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI; the District of Columbia and the countries of Belgium, India Italy, Spain, and United Kingdom.

    Quantity

    304