Events

Recall of Device Recall High Permeability Hemodialysis 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
    36199
  • Event Risk Class
    Class 2
  • Event Number
    Z-0032-2007
  • Event Initiated Date
    2006-05-16
  • Event Date Posted
    2006-10-12
  • 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=48178
  • 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
    A potential risk of infusing air or infusion fluid to the patient during dialysis. also, a possibility of an incorrect scale reading of the amount of patient fluid removal.
  • Action
    Consignees were notified by letter on 05/16/2006.

Device

Device Recall High Permeability Hemodialysis System
  • Model / Serial
    Serial numbers: PA0101 to PA0681.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, 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