Events

Recall of Device Recall NxStage

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
    38546
  • Event Risk Class
    Class 2
  • Event Number
    Z-1228-2007
  • Event Initiated Date
    2007-07-27
  • Event Date Posted
    2007-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53938
  • 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
    hemodialysis cartridge - Product Code KDI
  • Reason
    Potential for dialysate leaks from the cartridge during treatment.
  • Action
    NxStage initiated the recall by letter on 8/24/07 advising users of the specific lots to be removed from use. Prior notifications were issued on July 27, 2007, July 30, 2007 and July 31, 2007 notifying users of the potential for leaks and instructions to detect leaks prior to use.

Device

Device Recall NxStage
  • Model / Serial
    Lot Numbers: 7037802, 703803, 703804, 7047702, 7047703, 7047704, 7047705, 7057702, 7057703, 7057704, 7057705, 7057706, 7057707, 7057708, 7057709, 7067701, 7067702,7067703, 7067705, 7067709, 7067710, 7067711, 7067712, 7067713, 7067714, 7067715, 7077703.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    NxStage Cartridge Express, CAR-170, for hemodialysis.
  • Manufacturer
    NxStage Medical, Inc.

Manufacturer

NxStage Medical, Inc.
  • Manufacturer Address
    NxStage Medical, Inc., 439 South Union Street, 5th Floor, Lawrence MA 01843-2800
  • Source
    USFDA