BEUDAMED
    FDA Enforcement Class II Completed

    POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362

    Recall: Z-1761-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1761-2018
    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 1668362

    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) REAN0058 (01)00801741110740(17)170628(10)REAN0058 REAN0205 (01)00801741110740(17)170628(10)REAN0205 REAN1124 (01)00801741110740(17)170628(10)REAN1124 REAP0769 (01)00801741110740(17)170728(10)REAP0769 REAT1312 (01)00801741110740(17)171128(10)REAT1312 REBP1357 (01)00801741110740(17)180131(10)REBP1357 REBR0999 (01)00801741110740(17)180731(10)REBR0999 REBV0758 (01)00801741110740(17)180930(10)REBV0758

    Distribution

    Nationwide

    Quantity

    2395 units