BEUDAMED
    FDA Enforcement Class II Terminated

    NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration.

    Recall: Z-2793-2018 · Reported August 22, 2018

    Enforcement

    Recall Number
    Z-2793-2018
    Event ID
    80512
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NxStage Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2018
    Initiation Date
    June 11, 2018
    Classification Date
    August 13, 2018
    Termination Date
    April 28, 2020
    Address
    350 Merrimack St, Lawrence, MA, 01843-1748, United States

    Description

    NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration.

    Reason

    There is a potential risk of electrical fire when fluid leaks into the power receptacle on the back of the warmer. The risk exists any time the warmer is plugged in. The firm has received 7 reports of smoke, sparks, or flames coming from the Express Fluid Warmer since 2016. No adverse events have been reported.

    Code Info

    All units are affected. As of 6/11/18, the last serial number manufactured was W35452.

    Distribution

    Worldwide Distribution - US Nationwide in the countries of Australia, Canada, France, Germany, Italy, Kuwait, Netherlands, Saudi Arabia, Spain, Sweden, and UK.

    Quantity

    14975