Events

Recall of AVANTA FLUID INJECTION SYSTEM - MAIN UNIT WITH PEDESTAL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAYER MEDICAL CARE 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
    27447
  • Event Risk Class
    III
  • Event Initiated Date
    2010-11-09
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    There are 2 parts to this field correction. the avanta fluid management injection system operation manual and operational manual cd contain innacurate saline flow rate specifications. medrad has also received reports of reduced or no saline flow during purging of the avanta system disposables.

Device

AVANTA FLUID INJECTION SYSTEM - MAIN UNIT WITH PEDESTAL
  • Model / Serial
    Model Catalog: (Lot serial: 20208); Model Catalog: (Lot serial: 20191); Model Catalog: (Lot serial: 20051); Model Catalog: (Lot serial: 20550); Model Catalog: (Lot serial: 20575); Model Catalog: (Lot serial: 20465); Model Catalog: (Lot serial: 20458); Model Catalog: (Lot serial: 20071)
  • Product Description
    Avanta Fluid Injection System - Main unit with pedestal
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

BAYER MEDICAL CARE INC.
  • Manufacturer Address
    INDIANOLA
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    HC