BEUDAMED
    FDA Recall Terminated

    NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

    Recall: Z-1214-2013 · Initiated March 18, 2013

    Recall

    Recall Number
    Z-1214-2013
    Event Number
    64820
    Firm
    NxStage Medical, Inc.
    FEI Number
    3003464075
    Product Code
    KPO
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    March 18, 2013
    Posted
    May 2, 2013
    Terminated
    September 17, 2014
    Address
    350 Merrimack Street, Lawrence, MA, 01843-1748

    Description

    NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

    Reason

    Product may be mislabeled.

    Action

    NxStage sent a letter dated March 18, 2013, via email to all consignees instructing them to check their entire inventory and to segregate and quarantine lot F023444 pending further instruction from NxStage. On 4/2/13 NxStage sent a letter via email to all consignees requesting a return of all RFP-400 and RFP-401 labeled with lot F023444.. Consignees were instructed to complete the recall reply form and provide a list of customers (name address, phone number) and fax them to NXStage Medical, Inc. Customers with questions were instructed to call 1-866-697-8243. For questions regarding this recall call 1-866-697-8243.

    Distribution

    Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.

    Quantity

    1480 cases (2 bags per case)