BEUDAMED
    FDA Enforcement Class II Terminated

    Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-501J Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs

    Recall: Z-0630-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0630-2018
    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

    Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-501J Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs

    Reason

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

    Code Info

    Lot Number (Expiration date): 5918090 (29-May-2018), 5925813 (02-June-2018)

    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

    85