BEUDAMED
    FDA Enforcement Class II Completed

    POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300

    Recall: Z-1764-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1764-2018
    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 Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300

    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) REAN0060 (01)00801741110801(17)170628(10)REAN0060 REAN1126 (01)00801741110801(17)170628(10)REAN1126 REAP0475 (01)00801741110801(17)170728(10)REAP0475 REAP0511 (01)00801741110801(17)170728(10)REAP0511 REAY0813 (01)00801741110801(17)171031(10)REAY0813 REAY0800 (01)00801741110801(17)171031(10)REAY0800 REBP1202 (01)00801741110801(17)180131(10)REBP1202 REBP1622 (01)00801741110801(17)180131(10)REBP1622 REBS1267 (01)00801741110801(17)180731(10)REBS1267 REBR1122 (01)00801741110801(17)180930(10)REBR1122 REBS1784 (01)00801741110801(17)180930(10)REBS1784 REBU1162 (01)00801741110801(17)181130(10)REBU1162 REBV1757 (01)00801741110801(17)190228(10)REBV1757 REBX1546 (01)00801741110801(17)190331(10)REBX1546 REBY0830 (01)00801741110801(17)190430(10)REBY0830

    Distribution

    Nationwide

    Quantity

    2835 units