Events

Recall of Device Recall NxStage PureFlowB Solution

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by NxStage Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64820
  • Event Risk Class
    Class 2
  • Event Number
    Z-1214-2013
  • Event Initiated Date
    2013-03-18
  • Event Date Posted
    2013-05-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117126
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
  • 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.

Device

Device Recall NxStage PureFlowB Solution
  • Model / Serial
    F023444
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.
  • Product 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.
  • Manufacturer
    NxStage Medical, Inc.

Manufacturer

NxStage Medical, Inc.
  • Manufacturer Address
    NxStage Medical, Inc., 350 Merrimack Street, Lawrence MA 01843-1748
  • Manufacturer Parent Company (2017)
    Nxstage Medical Inc
  • Source
    USFDA