Events

Recall of Cooper Surgical TransWarmer Infant Transport Mattress (Produces heat through chemical reaction)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by In Vitro Technologies 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-2014-RN-00801-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00801-1
  • 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 few of the transwarmer infant transport mattresses have been found to have self-activated. as the transwarmer only stays warm for 4 hours, if it self-activates it can no longer be used.
  • Action
    Customers are asked to inspect and quarantine the affected stock. In Vitro Technologies will arrange the stock to be recovered. This action has been closed-out on 04/08/2016.

Device

Cooper Surgical TransWarmer Infant Transport Mattress (Produces heat through chemical reaction)
  • Model / Serial
    Cooper Surgical TransWarmer Infant Transport Mattress (Produces heat through chemical reaction)Catalogue number: UNI20421Batch number: 11463 ARTG number: 218101
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd