BEUDAMED
    FDA Enforcement Class II Terminated

    PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

    Recall: Z-1552-2021 · Reported May 19, 2021

    Enforcement

    Recall Number
    Z-1552-2021
    Event ID
    87656
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Peripheral Vascular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 19, 2021
    Initiation Date
    March 25, 2021
    Classification Date
    May 10, 2021
    Termination Date
    April 10, 2023
    Address
    1625 W 3rd St Bldg 1, Tempe, AZ, 85281-2438, United States

    Description

    PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

    Reason

    Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.

    Code Info

    Code: REEV2356, REEX1383, REEX3996

    Distribution

    US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV.

    Quantity

    287 units