Events

Recall of Device Recall Phoenix Hemodialysis machine.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gambro Renal Products, 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
    36233
  • Event Risk Class
    Class 2
  • Event Number
    Z-0200-2007
  • Event Initiated Date
    2006-05-12
  • Event Date Posted
    2006-11-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48227
  • 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 - Product Code KDI
  • Reason
    Defective heat exchanger/membrane; this may result in perforation of the membrane thus allowing the presence of infectious organisms and/or pathogens to pass from patient to patient.
  • Action
    Consignees were notified by fax on 05/12/2006 and by letter on 05/16/2006. Until it was determined that their Phoenix system did not have an affected heat exchanger, users were instructed to disinfect the hydraulics flow path after each patient treatment. Gambro personnel will inspect each system and replace any affected heat exchangers.

Device

Device Recall Phoenix Hemodialysis machine.
  • Model / Serial
    Serial numbers: 11637 thru 12321.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution, USA, including VA facilities in GA and NC. Foreign distribution to Canada, Korea and Mexico.
  • Product Description
    Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco S.p.A., Italy.
  • Manufacturer
    Gambro Renal Products, Inc.

Manufacturer

Gambro Renal Products, Inc.
  • Manufacturer Address
    Gambro Renal Products, Inc., 10810 W Collins Ave, Lakewood CO 80215-4439
  • Source
    USFDA