Events

Recall of FAKWP (Fineline 6100258) and FAKSITE (Fineline 5820595) First Aid Kits

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Scott Health and Safety.

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-01234-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-11-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01234-1
  • 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
    Scott safety has been advised by the supplier, pacsource, of the ‘10 ml normal saline for irrigation’ with batch number 1t2324002 included in the kits may not be sterile after failing the test for sterility undertaken by the tga.
  • Action
    Scott Safety is recalling all affected First Aid Kits and requesting that these kits should be returned to them immediately. Scott Safety will inspect and replace ‘10 ml Normal Saline for Irrigation’ with alternate component that has already been secured. All new stock will be clearly marked with a QC sticker next to the barcode. This action has been closed-out on 18/03/2016.

Device

FAKWP (Fineline 6100258) and FAKSITE (Fineline 5820595) First Aid Kits
  • Model / Serial
    FAKWP (Fineline 6100258) and FAKSITE (Fineline 5820595) First Aid Kits All lot NumbersARTG Number: 170275
  • Manufacturer
    Scott Health and Safety

Manufacturer

Scott Health and Safety
  • Source
    DHTGA