BEUDAMED
    FDA Enforcement Class II Ongoing

    US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082

    Recall: Z-1123-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1123-2020
    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

    US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082

    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 10HW4A57 10AX4A06 36ES4A15 36AR4A04 36AR4A06 36AR4A13 36HS4A10 36HS4A54 36JN4A04 36JN4A06 36JN4A07 36JN4A09 36JN4A13 36JN4A14 36JN4A15 36JN4A18 36JN4A23 36JN4A28 36JN4A35 36KN4A11 36KN4A16 36KN4A23 36KN4A27 36KN4A33 36KN4A34 36KN4A41 36HS4A01 10IT4A21 36HS4A14 36HS4A26 36BS4A17 36ES4A28 36ES4A33 36ES4A08 10IT4A16 36FR4A13 36HS4A61 10ET4A07 36HS4A46 10ET4A20 36HS4A25 36HS4A43 10ET4A02

    Distribution

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

    Quantity

    6670 (US)