BEUDAMED
    FDA Enforcement Class II Terminated

    Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.

    Recall: Z-0996-2013 · Reported April 3, 2013

    Enforcement

    Recall Number
    Z-0996-2013
    Event ID
    63621
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 3, 2013
    Initiation Date
    May 14, 2010
    Classification Date
    March 26, 2013
    Termination Date
    April 11, 2013
    Address
    1265 Grey Fox Rd, Saint Paul, MN, 55112-6929, United States

    Description

    Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.

    Reason

    An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions.

    Code Info

    Lot/Serial Numbers: M76369, M76370, M76373, M76374, M76375, and M76377.

    Distribution

    Distributed in the state of NH.

    Quantity

    6