Events

Recall of Transradial Artery Access Kits

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Mayo Healthcare 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-2013-RN-01087-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01087-1
  • 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
    The manufacturer has advised that this action is due to a foreseen risk that the introducer needles packaged within the kits can be partially or fully occluded. if an occluded needle is used on a patient, there is risk of delay in treatment and/or adverse event requiring medical intervention.
  • Action
    Customers are asked to quarantine any affected stock. Mayo Healthcare customer service will contact customers with affected stock to arrange return, dispatch of replacement stock, or issuance of a credit note.

Device

Transradial Artery Access Kits
  • Model / Serial
    Transradial Artery Access Kits Product Codes: AA106111, AA15511-S, AA15611-SMultiple serial numbersARTG Number: 135922
  • Manufacturer
    Mayo Healthcare Pty Ltd

Manufacturer

Mayo Healthcare Pty Ltd