Events

Recall of Cook Biodesign 1-Layer Tissue Graft and Cook Biodesign 4-Layer Tissue Graft

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by William A Cook Australia 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-2017-RN-00328-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00328-1
  • 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
    Cook medical is instigating a change in the intended use wording of the product instructions for use (ifu). this change is in response to the report of two potential adverse events during use in urological or gynecological procedures. this change will provide clarification of the product's intended use, with the addition of the following statement in the ifu: "this device is not intended for use in urological or gynaecological procedures".
  • Action
    Cook is advising users of an update to the intended use in the instructions for use to clarify that the devices are not intended for use in urological or gynaecological procedures. A new version of the instructions for use that includes the updated intended use will be introduced within the next few months. In the interim, each device will be supplied with a leaflet that includes notice of the update.

Device

Cook Biodesign 1-Layer Tissue Graft and Cook Biodesign 4-Layer Tissue Graft
  • Model / Serial
    Cook Biodesign 1-Layer Tissue Graft and Cook Biodesign 4-Layer Tissue GraftCook Biodesign 1-Layer Tissue Graft Model Numbers: C-SLH-1S-2X3, C-SLH-1S-7X10, SLH-1S-7X10Cook Biodesign 4-Layer Tissue GraftModel Numbers: C-SLH-4S-1X10, C-SLH-4S-2X3, C-SLH-4S-4X7, C-SLH-4S-7X10, C-SLH-4S-7X20, J-SLH-4S-7X20, J-SLH-4S-4X7, J-SLH-4S-7X10, SLH-4S-2X3, SLH-4S-3.5X5, SLH-4S-4X7, SLH-4S-7X10, SLH-4S-7X20ARTG Number: 153047
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd