Events

Recall of Device Recall Gambro Prismaflex

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
    37306
  • Event Risk Class
    Class 2
  • Event Number
    Z-0695-2007
  • Event Initiated Date
    2007-01-04
  • Event Date Posted
    2007-03-31
  • 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=50323
  • 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 machine - Product Code KDI
  • Reason
    Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines).
  • Action
    Customers were notified by letter on 12/19/2006. They were told that Gambro would schedule the required upgrades to their equipment and not to use the current syringe for delivering anticoagulant.

Device

Device Recall Gambro Prismaflex
  • Model / Serial
    Serial numbers: PA0101 thru PA0681, PA1001 thru PA1774.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution -- including states of AL, CA, FL, GA, IN, MD, ME, MI, MS, NC, NH, NY, OH, PA, SC, TX, VA, and WI.
  • Product Description
    Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.
  • 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