Events

Recall of Endoscopic Curved Needle Driver, LapSac Introducer and LapSac Introducer Set

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-00584-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00584-1
  • 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 have identified that the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilisation of specific endoscopic curved needle driver, lapsac introducer and lapsac introducer set products. preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidance. to date, the manufacturer has received no reports of adverse reactions related to inadequate cleaning, disinfection, or sterilisation associated with these devices. potential adverse events that may occur if the products are not adequately reprocessed include localised surgical site infection, to deeper organ space infection, as well as chemical residual exposure.
  • Action
    Cook Medical is advising users to examine their inventory immediately to identify and quarantine any affected products. Products are to be discarded or returned to Cook Medical.

Device

Endoscopic Curved Needle Driver, LapSac Introducer and LapSac Introducer Set
  • Model / Serial
    Endoscopic Curved Needle Driver, LapSac Introducer and LapSac Introducer SetEndoscopic Curved Needle DriverCatalogue Numbers: 096511, J-ENH-033100, J-ENH-053100, J-ENH-053120 and J-ENH-053130ARTG Number: 212233LapSac IntroducerCatalogue Number: J-LSI-102500ARTG Number: 276893LapSac Introducer SetCatalogue Number: 054300Previous ARTG Number: 276893All Lots
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd