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
    67405
  • Event Risk Class
    Class 2
  • Event Number
    Z-1073-2014
  • Event Initiated Date
    2014-01-24
  • Event Date Posted
    2014-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125408
  • 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
    Mislabeled product.
  • Action
    NxStage sent a Voluntary Medical Device Recall letter dated January 24, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were asked to check all boxes in inventory for the recalled lot and segregate and quarantine them. In addition, they were asked to complete the recall reply form and return it by fax to NxStage Medical as well as to contact NxStage Customer service to arrange for return of all affected product and for replacement to be sent. Distributor was asked to notify all downstream customers and to provide NxStage Medical with a list of customers. Please complete and fax this form to 978-687-4810 even if you do not have any of the affected product on hand. If you have any questions or comments, please feel free to contact NxStage Customer Service at 1-866- NXSTAGE (1-866-697-8243).

Device

Device Recall NxStage PureFlowB Solution
  • Model / Serial
    Lot Number: F113662
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of NY, TX, ID, AR, CA and AL
  • Product Description
    NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. || 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