BEUDAMED
    FDA Enforcement Class II Terminated

    Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner.

    Recall: Z-0242-2016 · Reported November 18, 2015

    Enforcement

    Recall Number
    Z-0242-2016
    Event ID
    72331
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    WalkMed Infusion, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 18, 2015
    Initiation Date
    October 1, 2015
    Classification Date
    November 6, 2015
    Termination Date
    July 12, 2016
    Address
    6555 S Kenton St Ste 304, N/A, Englewood, CO, 80111-6838, United States

    Description

    Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner.

    Reason

    The device might fail to detect air in line while infusing the medication Venofer. This may occur when a drop of Venofer gets stuck in the tubing adjacent to the bubble detector and the Total Volume Limit is programmed higher than the actual bag volume.

    Code Info

    Model numbers 300000, 400000

    Distribution

    Distributed in the states of AL, CA, CO, DE, FL, GA, IL, MA, MD, MI, MN, MS, NC, NJ, NM, NV, NY, OH, PA, TN, TX, and WA.

    Quantity

    4695 units