Events

Recall of Dialysis tubing set

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
    34080
  • Event Risk Class
    Class 2
  • Event Number
    Z-0705-06
  • Event Initiated Date
    2005-10-24
  • Event Date Posted
    2006-04-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43082
  • 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
    Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
  • Reason
    After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.
  • Action
    Recall information was forwarded to all Gambro Sale Organizations. Notification was sent to all US consignees on November 2nd and November 3rd, 2005.

Device

Dialysis tubing set
  • Model / Serial
    Lot numbers 04K2692P, 05A0754P, 05D1571, 05F0763A, 05F0865, 05F0966, 05F1573G, 05F1574, 05F1675G, 05F2387G, 05F3098G, 05G0556G, 05G0760G, 05G1366G. Recall expanded on 04/13/2006 to include 05AXXXXX through 05J2796P.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including VA facilities in AZ, CA, DC, FL, GA, MI, MO, NJ, NY, OH, OR, PA, PR, TX, UT, VA, WI. Military distribution to CA and TX. Foreign distribution to Australia, Canada, Denmark, France, Germany, Hungary, UK.
  • Product Description
    Gambro Prisma M100 preset, Part No. 8353486.
  • 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