Events

Recall of Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Imaxeon Pty Ltd.

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
    RC-2016-RN-01498-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-11-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01498-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Imaxeon have determined that all current source administration sets (sas) used with the medrad intego pet infusion system may produce particulates in radiopharmaceutical (rp) vials when the needle is inserted. these particulates may be generated when the tip of the needle pushes through the rubber septum of the vial. this presents a potential safety risk of particulate(s) being injected into a patient. to date, there have been no reports of patient or user injury.
  • Action
    Imaxeon is advising customers to immediately discontinue use of the Intego system and quarantine the SAS disposable units that they have in stock. They are also advised to determine an alternative method of the radiopharmaceutical delivery such as manual injections, if feasible. Imaxeon is in the process of qualifying a compatible in-line filter to be used with the SAS and will advise customers of the results in the next few weeks. Due to the limited inventory, customers may retain their quarantined units to be later used with the in-line filters. Alternatively, customers may return their units back to Imaxeon for a credit.

Device

Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System

Manufacturer

Imaxeon Pty Ltd
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    DHTGA