BEUDAMED
    FDA Enforcement Class II Ongoing

    Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)

    Recall: Z-1125-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1125-2020
    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 Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)

    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.

    Distribution

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

    Quantity

    1083 (OUS)