Events

Recall of Percutaneous Sheath Introducer 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-2014-RN-00473-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-04-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00473-1
  • 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 initiated this recall due to tip damage noticed during internal inspection of the dilator tip of the percutaneous sheath introducer found in the above referenced kits. tip damage has the potential to result in vessel damage.
  • Action
    Mayo Healthcare is requesting end users to inspect their stock and quarantine any units from the affected batches. Mayo Healthcare will contact customers to arrange for the recovery of affected devices.

Device

Percutaneous Sheath Introducer Kits

Manufacturer

Mayo Healthcare Pty Ltd