BEUDAMED
    FDA Enforcement Class II Terminated

    PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070

    Recall: Z-1300-2014 · Reported April 2, 2014

    Enforcement

    Recall Number
    Z-1300-2014
    Event ID
    67567
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Access Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 2, 2014
    Initiation Date
    February 27, 2014
    Classification Date
    March 27, 2014
    Termination Date
    September 5, 2014
    Address
    605 North 5600 West, N/A, Salt Lake City, UT, 84116-3738, United States

    Description

    PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070

    Reason

    Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a PowerPort Slim titanium implantable port without silicone suture plugs.

    Code Info

    Lot Numbers: REXA1302, REXA1350, REXB1160

    Distribution

    US Nationwide distribution including WA, KY, IL, and IA.

    Quantity

    777