BEUDAMED
    FDA Enforcement Class II Ongoing

    Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.

    Recall: Z-1184-2021 · Reported March 17, 2021

    Enforcement

    Recall Number
    Z-1184-2021
    Event ID
    87265
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medical Components, Inc dba MedComp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 17, 2021
    Initiation Date
    January 13, 2021
    Classification Date
    March 8, 2021
    Address
    1499 Delp Dr, Harleysville, PA, 19438-2936, United States

    Description

    Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.

    Reason

    The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure.

    Code Info

    Catalog Number: MRDP50AXS, Lot Number: MPDX180, UDI Number: 884908149753 (updated 3/11/2021 added lot number: MPCY660)

    Distribution

    US Nationwide distribution in the states of CA, DC, GA, IL, IN, MA, MI, NJ, NM, NY, OH, PA, TX. Updated 3/11/2021

    Quantity

    96 pieces total (updated 3/11/2021 additional 72 pieces)