Events

Recall of Device Recall Premixed Dialysate for Hemodialysis

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
    79276
  • Event Risk Class
    Class 2
  • Event Number
    Z-1132-2018
  • Event Initiated Date
    2017-11-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161806
  • 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
    Using different fluid formulations of nxstage pureflow b solution at the same time during treatment may cause patient health risk. the nxstage pureflow b solution is for use with systems that use one premixed dialysate during hemodialysis. the original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use.
  • Action
    Customers are advised to : 1. Always make sure when using PureFlow B Solution that fluid is flowing freely from all bags. 2. Recognize that any practice of hanging more than one fluid type at the same time is not an intended use of the NxStage System One" (as it does not monitor fluid composition) and is not a labeled indication of PureFlow B solutions. 3. Please make sure that all users of PureFlow B Solution in your organization and other concerned persons are informed regarding this Field Safety Notice. 4. Complete the enclosed customer reply form and return it to NxStage. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices.

Device

Device Recall Premixed Dialysate for Hemodialysis
  • Model / Serial
    RFP-400 - M535RFP4000 RFP-400-BB - 00842289101258 RFP-401 M - 535RPF4010 RFP-401-BB - 00842289101265 RFP-402 - M535RFP4020 RFP-403 - M535RFP4030 RFP-404- M535RFP4040 RFP-405 - M535RFP4050 RFP-406 - M535RFP4060 RFP-453 - M535RFP4530 RFP-454 - M535RFP4540 RFP-455 - M535RFP4550 RFP-456 - M535RFP4560
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US nationwide distribution
  • Product Description
    NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
  • 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