Events

Recall of Device Recall Prismaflex

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gambro Renal Products, Incorporated.

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
    58208
  • Event Risk Class
    Class 2
  • Event Number
    Z-1901-2011
  • Event Initiated Date
    2011-03-14
  • Event Date Posted
    2011-04-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98675
  • 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
    Prismaflex touch screen may become unresponsive during continuous renal replacement therapy procedure.
  • Action
    The firm, GAMBRO Renal Products, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated March 14, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were provided with response procedures to use if the frozen screen problem occurs while using the product. The customers were instructed to closely monitor the return line for potential air and/or clots in the circuit; review the instructions provided in the attached copy of Chapter 5: Troubleshooting, "Softkeys won't work." of the Prismaflex Operators Manual in conjunction with the attached Troubleshooting Checklist; be aware if performing Manual Termination with Blood Return, air detection is not provided, and complete and return the Customer Reply Form via fax to: Regulatory Affairs at 1-866-447-4471 or 303-222-6916, or by email to: GRPRegulatory.Affairs@us.gambro.com. If you have any questions or concerns, please contact for Clinical questions: ICON 800-554-1312 (available 24/7) or your local Gambro Representative; for Technical questions: Gambro Customer Support 800-525-2623, option 2 (Available 6:00am to 5:30pm MT, Monday thru Friday).

Device

Device Recall Prismaflex
  • Model / Serial
    All units with Version 3.20 software.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    Prismaflex System, Catalog Number 107493, || Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload.
  • Manufacturer
    Gambro Renal Products, Incorporated

Manufacturer

Gambro Renal Products, Incorporated
  • Manufacturer Address
    Gambro Renal Products, Incorporated, 14143 Denver West Pkwy, Lakewood CO 80401-3266
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA