BEUDAMED
    FDA Recall Terminated

    6.6F Plastic Dignity Low Profile CT Port W/Attachable ChronoFlex Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: Indicated for patient therapies requiring repeated access to the vascular system. 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. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media.

    Recall: Z-0533-2018 · Initiated May 25, 2017

    Recall

    Recall Number
    Z-0533-2018
    Event Number
    78221
    Firm
    Medical Components, Inc dba MedComp
    FEI Number
    2518902
    Product Code
    LJT
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    May 25, 2017
    Terminated
    September 4, 2018
    Address
    1499 Delp Dr, Harleysville, PA, 19438-2936

    Description

    6.6F Plastic Dignity Low Profile CT Port W/Attachable ChronoFlex Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: Indicated for patient therapies requiring repeated access to the vascular system. 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. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media.

    Reason

    The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip.

    Action

    On May 25, 2017, Medcomp distributed Product Recall notices to their customers via email. Medcomp requested the return of all un-used affected product. Customers were advised to immediately examine inventory and to quarantine product subject to recall. If product was further distributed, notification of the recall to those individuals is required. Contact your customer service representative for a Returned Goods Authorization (RGA) number if necessary. The request can be made by telephone by calling 215-256-4201.

    Distribution

    Arabia, Australia, Israel, Brunei & Jamaica

    Quantity

    65 units