BEUDAMED
    FDA Recall Terminated

    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1 Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 40

    Recall: Z-1858-2014 · Initiated May 14, 2014

    Recall

    Recall Number
    Z-1858-2014
    Event Number
    68354
    Firm
    NxStage Medical, Inc.
    FEI Number
    3003464075
    Product Code
    FKR
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    May 14, 2014
    Posted
    June 24, 2014
    Terminated
    March 13, 2017
    Address
    350 Merrimack Street, Lawrence, MA, 01843-1748

    Description

    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1 Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 40

    Reason

    SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

    Action

    NxStage issued Initial recall letter dated 5/14/14 to dialysis centers. An error was noted and an updated letter dated 5/15/14 was resent to dialysis centers. The updated 5/15/14 letter was emailed to all current active PureFlow SL patients who had provided an email address followed by UPS next business day letter sent to all current active PureFlow SL patients. Accounts are requested to examine inventory and remove product. Contact NxStage Customer Service to arrange for return of all affected product and for replacement product to be sent. If you have any questions or comments, please feel free to contact NxStage Customer Service at 1-866-NXSTAGE (1-866-697-8243).

    Distribution

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

    Quantity

    2839 cases