Events

Recall of MEDRAD INTEGO PET INFUSION SYSTEM - SOURCE ADMINISTRATION SET

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
    141491
  • Event Risk Class
    I
  • Event Initiated Date
    2016-11-09
  • 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
    After investigation of the returned product it was confirmed that particulate may be generated when the tip of the needle pushes through the rubber septum of the vial. this presents a potential safety risk of a particulate being injected into a patient and while remote a potential risk of significant harm exists.

Device

MEDRAD INTEGO PET INFUSION SYSTEM - SOURCE ADMINISTRATION SET
  • Model / Serial
    Model Catalog: INT CSS (Lot serial: >10. Contact Manufacturer.)
  • Product Description
    Medrad Intego PET Infusion System - Source Administration Sets
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

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