BEUDAMED
    FDA Enforcement Class II Completed

    POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362

    Recall: Z-1767-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1767-2018
    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 ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362

    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) REAN0059 (01)00801741110757(17)170628(10)REAN0059 REAN1125 (01)00801741110757(17)170628(10)REAN1125 REAP0627 (01)00801741110757(17)170728(10)REAP0627 REBN2011 (01)00801741110757(17)180131(10)REBN2011 REBP0853 (01)00801741110757(17)180131(10)REBP0853 REBS1276 (01)00801741110757(17)181031(10)REBS1276 REBS2291 (01)00801741110757(17)181130(10)REBS2291 REBU1357 (01)00801741110757(17)181231(10)REBU1357 REBW1455 (01)00801741110757(17)190331(10)REBW1455 REBY0778 (01)00801741110757(17)190430(10)REBY0778

    Distribution

    Nationwide

    Quantity

    4044 units