BEUDAMED
    FDA Enforcement Class II Terminated

    9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling.

    Recall: Z-1527-2015 · Reported May 6, 2015

    Enforcement

    Recall Number
    Z-1527-2015
    Event ID
    70457
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Components, Inc dba MedComp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2015
    Initiation Date
    January 28, 2015
    Classification Date
    April 27, 2015
    Termination Date
    January 6, 2017
    Address
    1499 Delp Dr, Harleysville, PA, 19438, United States

    Description

    9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling.

    Reason

    The dual port with catheters was not covered under FDA clearance.

    Code Info

    Model No. MR592090A, MR592090P; with Lot Nos.: MAKT120 EXP. DATE 04/28/2012, MAXH410 EXP. DATE 06/28/2014, MAXF610 EXP. DATE 10/28/2014, MBFC140 EXP. DATE 05/28/2016, MBGH020 EXP. DATE 08/28/2016, MBHS100 EXP. DATE 11/28/2016, MAKT130 EXP. DATE 04/28/2012, MBAQ860 EXP. DATE 07/28/2015, MBHP980 EXP. DATE 11/28/2016, MBKJ110 EXP. DATE 03/28/2017

    Distribution

    Worldwide distribution. US nationwide, Canada, Brazil, and United Arab Emirates.

    Quantity

    325