BEUDAMED
    FDA Enforcement Class II Terminated

    DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility

    Recall: Z-2360-2019 · Reported September 4, 2019

    Enforcement

    Recall Number
    Z-2360-2019
    Event ID
    83017
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Leventon S. A. U.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2019
    Initiation Date
    May 23, 2019
    Classification Date
    August 23, 2019
    Termination Date
    June 8, 2020
    Address
    Calle Newton 18 24, Sant Esteve Sesrovires, Barcelona, N/A, N/A, Spain

    Description

    DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility

    Reason

    The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.

    Code Info

    172055L, 1721 10L, 1 807881, 181 1401 Unique Device Identifier (UDI) 08436020767470, 08436020768026

    Distribution

    US Distribution to states in: AZ, CA, MA, MI, PR, and FL.

    Quantity

    1700