BEUDAMED
    FDA Enforcement Class II Terminated

    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-407 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100 Batch Size (liters) 50

    Recall: Z-1861-2014 · Reported July 2, 2014

    Enforcement

    Recall Number
    Z-1861-2014
    Event ID
    68354
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NxStage Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2014
    Initiation Date
    May 14, 2014
    Classification Date
    June 24, 2014
    Termination Date
    March 13, 2017
    Address
    350 Merrimack Street, N/A, Lawrence, MA, 01843-1748, United States

    Description

    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-407 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100 Batch Size (liters) 50

    Reason

    SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

    Code Info

    Lot code: 40179074

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.

    Quantity

    91 cases