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
    55073
  • Event Risk Class
    II
  • Event Initiated Date
    2016-10-05
  • 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 november 2015 during a review of historical intego sas testing it was discovered that documented test evidence related to 85 psi for 35 seconds could not be found. when the necessary testing was recently conducted some failures were found at three year simulated age testing. the failed samples exhibited leaks in the coil bond joint. there was no test failures of the samples at one year accelerated age. product is currently labeled with a 3 year shelf-life and thus needs to be corrected until this shelf-life can be re- established.

Device

MEDRAD INTEGO PET INFUSION SYSTEM - SOURCE ADMINISTRATION SET
  • Model / Serial
    Model Catalog: INT CSS (Lot serial: More than 10-contact manuf.)
  • Product Description
    MEDRAD INTEGO PET INFUSION SYSTEM - SOURCE ADMINI
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

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