BEUDAMED
    FDA Recall Terminated

    Thora-Para 5 Fr Non-Valved Catheter Drainage Tray

    Recall: Z-2646-2020 · Initiated May 28, 2020

    Recall

    Recall Number
    Z-2646-2020
    Event Number
    85751
    Firm
    Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845
    FEI Number
    3008002452
    Product Code
    PXI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 28, 2020
    Terminated
    September 20, 2024

    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.

    Action

    All affected consignees are being notified via FedEx mailed letter and/or email beginning 6/15/2020. BD requests a sub-recall to be conducted if product has been further distributed. Consignees are asked to complete the acknowledgement form included with the notification letter and return to BD.

    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.