Events

Recall of AVANTA FLUID INJECTION SYSTEM - HAND CONTROLLER STERILE SHEATH

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
    27740
  • Event Risk Class
    II
  • Event Initiated Date
    2012-11-13
  • 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
    In certain packages the seal between the white polyethylene and the clear plastic may be missing on the hand controller sheath package resulting in a potential breach of the sterility of this accessory.

Device

AVANTA FLUID INJECTION SYSTEM - HAND CONTROLLER STERILE SHEATH
  • Model / Serial
    Model Catalog: AVA 500 HCS (Lot serial: distributed from March 2008); Model Catalog: AVA 500 HCS (Lot serial: > 100 lot numbers); Model Catalog: AVA 500 HCS (Lot serial: contact Manufacturer)
  • Product Description
    Medrad Hand Controller Sheats #AVA500 HCS
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

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