BEUDAMED
    FDA Enforcement Class II Ongoing

    Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242

    Recall: Z-1122-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1122-2020
    Event ID
    84653
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Flowonix Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2020
    Initiation Date
    December 24, 2019
    Classification Date
    February 10, 2020
    Address
    120 Forbes Blvd Ste 170, Mansfield, MA, 02048-1150, United States

    Description

    Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242

    Reason

    A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

    Code Info

    All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers 10GC4A24X 10GC4A02X 10GC4A18X 10GC4A22X 10GC4A14X 4MA00044X 4MA00006X 10GC4A12X 10GC4A09X 10GC4A06X 10GC4A21X 4MA00008X 10GC4A01X 10GC4A20X 10GC4A11X 10GC4A16X 10GC4A17X 4MA00045X 4MA00055X 10GC4A08X 4MA00032X 4MA00031X 4MA00010X 4MA00042X

    Distribution

    Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.

    Quantity

    6670 (US)