Events

Recall of Phoenix Hemodialysis Delivery System

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
    45950
  • Event Risk Class
    Class 2
  • Event Number
    Z-1367-2008
  • Event Initiated Date
    2007-09-10
  • Event Date Posted
    2008-03-25
  • 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=66565
  • 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
    Dialysis system - Product Code KDI
  • Reason
    Kinked tubing on hemodialysis device may cause hemolysis.
  • Action
    On September 10, 2007, the firm sent an Advisory Notice to all consignees alerting them that a kink in the tubing can result in physical hemolysis. The firm included with the Notice a Quick Reference Guide that provides drawing of the proper installation of the Phoenix and describes how to prevent bloodline kinking. A customer reply form was also included. The firm is in the process of making labeling changes that will be released with the updated software revisions.

Device

Phoenix Hemodialysis Delivery System
  • Model / Serial
    All catalog numbers involving the Gambro Cartridge Blood Sets: 003409-400, 003409-410, 003410-500, 003410-510, 004310-710, 003411-500, 003412-500, 003414-500, 003414-510, 003415-510, 003422-500, 003422-515, 003422-520, 003429-500.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including 17 VA facilities and 1 military facility. Foreign distribution to Canada, Korea, Mexico.
  • Product Description
    Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+) Hemodialysis System, Gambro, Lakewood, CO 80401
  • Manufacturer
    Gambro Renal Products, Inc.

Manufacturer

Gambro Renal Products, Inc.
  • Manufacturer Address
    Gambro Renal Products, Inc., 14143 Denver West Pkwy, Lakewood CO 80401-3116
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA