BEUDAMED
    FDA Enforcement Class II Terminated

    MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.

    Recall: Z-1868-2012 · Reported July 4, 2012

    Enforcement

    Recall Number
    Z-1868-2012
    Event ID
    62238
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Components, Inc dba MedComp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 4, 2012
    Initiation Date
    April 2, 2012
    Classification Date
    June 26, 2012
    Termination Date
    May 20, 2013
    Address
    1499 Delp Dr, Harleysville, PA, 19438, United States

    Description

    MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.

    Reason

    Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.

    Code Info

    Catalog number MRCTT80041, Lot # MDNK860, Exp 02/2015

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey.

    Quantity

    30