Events

Recall of Device Recall Polyflux Revaclear

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
    69786
  • Event Risk Class
    Class 2
  • Event Number
    Z-0490-2015
  • Event Initiated Date
    2014-11-05
  • Event Date Posted
    2014-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131540
  • 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
    Gambro is initiating a field action for polyflux revaclear dialyzer and polyflux revaclear max dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.
  • Action
    Recall letter was sent via UPS delivery next day to US customers on November 5th, 2014. Product that is returned will be quarantined at the distribution centers.

Device

Device Recall Polyflux Revaclear
  • Model / Serial
    Lot No C412207001 to C412209101, C413200101 to C413206001, C414200101 to C414206001
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.
  • Product Description
    Polyflux Revaclear Max Dialyzer, Model Number 110634. || The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
  • Manufacturer
    Gambro Renal Products Inc

Manufacturer

Gambro Renal Products Inc
  • Manufacturer Address
    Gambro Renal Products Inc, 1101 Jeter Ave, Opelika AL 36801-3885
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA