BEUDAMED
    FDA Enforcement Class II Terminated

    Thora-Para 5 Fr Non-Valved Catheter Drainage Tray

    Recall: Z-2646-2020 · Reported July 29, 2020

    Enforcement

    Recall Number
    Z-2646-2020
    Event ID
    85751
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carefusion 2200 Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 29, 2020
    Initiation Date
    May 28, 2020
    Classification Date
    July 18, 2020
    Termination Date
    September 20, 2024
    Address
    75 N Fairway Dr, N/A, Vernon Hills, IL, 60061-1845, United States

    Description

    Thora-Para 5 Fr Non-Valved Catheter Drainage Tray

    Reason

    The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

    Code Info

    Catalog: OTP5000; UDI: 50885403284746; Batches 0001319437, 0001320128, 0001321277, 0001321728, 0001322907, 0001324316, 0001332577, 0001334404, 0001335108, 0001336587, 0001337314, 0001338451, 0001339415, 0001341205, 0001342585, 0001344650, 0001346669, 0001346992

    Distribution

    370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded.

    Quantity

    N/A