Events

Recall of American Surgical Company (ASC ) Neuro Sponges Products affected: Americot Blue sponges, Cotton Balls, Ray-Cot sponges, Delicot sponges, Uniqcot sponges and Telfa sponges

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Life Healthcare 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-2016-RN-00433-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00433-1
  • 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
    A failure in the sterile peel pouch has been discovered during a quality control inspection by the manufacturer, asc. this failure may result in a small tear in the pouch of the device leading to a potential compromised sterile barrier. a leak in the sterile barrier may allow contamination of the device increasing the risk of infection. a comprehensive investigation has identified an occurrence rate of less than 0.01% for the affected lots.
  • Action
    LifeHealthcare is advising users to inspect stock and quarantine any remaining product for return. This action has been closed-out on 30/01/2017.

Device

American Surgical Company (ASC ) Neuro Sponges Products affected: Americot Blue sponges, Cotton B...
  • Model / Serial
    American Surgical Company (ASC ) Neuro Sponges Products affected: Americot Blue sponges, Cotton Balls, Ray-Cot sponges, Delicot sponges, Uniqcot sponges and Telfa spongesMultiple item and lot numbers affected (see attached)ARTG Numbers: 265712, 265713 and 146103
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd