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
    34318
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-21
  • 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
    The inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. the occluded sas tubing may impair the priming function and prompt an "rp prime failed. check sas and vial installation then reprime." error message.

Device

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

Manufacturer

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