Events

Recall of PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in) 90 deg

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smiths Medical Australasia 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-2015-RN-00944-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-09-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00944-1
  • 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
    Smiths medical has become aware of a labelling issue with one lot of port-a-cath plastic hub needles. the label on the lid stock of the individual needle package lists the incorrect product reorder number, description and product image. the product reorder number should be 21-2287-24 with a corresponding description and product image, but instead it lists the 21-2005-24 product reorder number, description and product image. the needle inside the individual package is the product reorder no. 21-2287-24 needle and the outer carton label lists the correct reorder number 21-2287-24.
  • Action
    Smiths Medical is advising customers to quarantine affected stock. Any affected stock will be replaced or a credit issued.

Device

PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in) 90 deg
  • Model / Serial
    PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in) 90 degProduct re-order Number: 21-2287-24Lot Number: 46262ARTG Number: 145298
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd