Events

Recall of Skin Graft Knife Blades for use with Thackray Watson Cobbett and Braithwaite Skin Graft Knife (Pack of 10 blades)

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

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-00654-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00654-1
  • 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
    There have two reports of product found during use where the terminally sterile packaging has not been fully sealed. the manufacturer is advising that the issue remains isolated to batch 6561302 and will be evident prior to use.
  • Action
    Customers are advised to ensure that the affected batch is isolated. Random Parts will arrange for the affected stock to be collected and replaced.

Device

Skin Graft Knife Blades for use with Thackray Watson Cobbett and Braithwaite Skin Graft Knife (Pa...
  • Model / Serial
    Skin Graft Knife Blades for use with Thackray Watson Cobbett and Braithwaite Skin Graft Knife (Pack of 10 blades)Product Code: 667455Lot Number: 6561302ARTG Number: 122572
  • Manufacturer
    Random Parts

Manufacturer

Random Parts
  • Source
    DHTGA