Events

Recall of Stainless Steel Scissor, Universal Shear, Blue Handle

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Tollot Pty Ltd T/a Aaxis Pacific.

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-00343-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-03-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00343-1
  • 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 blue plastic handle of the shear scissors may stain the peel pouch during autoclaving.
  • Action
    Aaxis Pacific is requesting hospitals and clinics to quarantine all units from the affected batches. Arrangements will be made for the recovery of the stock by Aaxis Pacific and replacement with unaffected stock.

Device

Stainless Steel Scissor, Universal Shear, Blue Handle
  • Model / Serial
    Stainless Steel Scissor, Universal Shear, Blue HandleProduct Code: 10110113Lot numbers: 002134 and 002076ARTG number: 167431
  • Manufacturer
    Tollot Pty Ltd T/a Aaxis Pacific

Manufacturer

Tollot Pty Ltd T/a Aaxis Pacific