Events

Recall of Cook LapSac Surgical Tissue Pouch

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-2015-RN-00500-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00500-1
  • 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
    Updates to the ifu are being made to discourage use of laparoscopic power morcellation in cases where the presence of cancerous tissue cannot be ruled out. the intended use for the device is being modified from "used to isolate tissue during, or prior to, surgical removal and or morcellation" to "used to isolate tissue during, or prior to surgical removal". a contraindication i.E., 'not for use with power morcellators' is also being added to the ifu. additionally, warnings and instructions in the ifu is being updated.
  • Action
    Customers are advised to pass the customer letter on to appropriate personnel within their organisation or to any organisation where the potentially affected devices have been transferred. This action has been closed-out on 26/08/2016.

Device

Cook LapSac Surgical Tissue Pouch

Manufacturer

William A Cook Australia Pty Ltd