BEUDAMED
    FDA Enforcement Class II Completed

    POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362

    Recall: Z-1760-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1760-2018
    Event ID
    79841
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Bard Peripheral Vascular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 16, 2018
    Initiation Date
    February 8, 2018
    Classification Date
    May 9, 2018
    Address
    1625 W 3rd St Bldg 1, N/A, Tempe, AZ, 85281-2438, United States

    Description

    POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362

    Reason

    The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

    Code Info

    Lot Number Unique Device Identifier (UDI) REAN0063 (01)00801741110726(17)170628(10)REAN0063 REAN1123 (01)00801741110726(17)170628(10)REAN1123 REAP0467 (01)00801741110726(17)170728(10)REAP0467 REAY1733 (01)00801741110726(17)180331(10)REAY1733 REBS1266 (01)00801741110726(17)180731(10)REBS1266 REBV1731 (01)00801741110726(17)181231(10)REBV1731 REBX1626 (01)00801741110726(17)190331(10)REBX1626 REBY0777 (01)00801741110726(17)190430(10)REBY0777

    Distribution

    Nationwide

    Quantity

    359 units