Events

Recall of Transwarmer Infant Transport Mattress

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ferno 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-00371-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00371-1
  • 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
    Coopersurgical has identified that there may be product with customers that have been in inventory for more than five years. some users of the transwarmer infant transport mattress may have removed individual units from the original packaging and have been using the device past the labelled and recommended expiration date.Serious burns have been reported in the past and could occur if the products are not stored under the labelled conditions or used beyond the recommended shelf life. coopersurgical has received three complaints from the field indicating that the product may activate at higher than labelled temperatures.
  • Action
    CooperSurgical is requesting all users to review their inventory and discard or return any product that does not display a product LOT code or expiration date on each individual unit. The brands affected include CooperSurgical and NovaPlus labelled TransWarmer Infant Transport Mattress. The LOT code and expiration date can be located on the top left corner of the individual pouches. All new units will have the lot and expiry date on the individual unit packaging. This action has been closed-out on 17/05/2017.

Device

Transwarmer Infant Transport Mattress
  • Model / Serial
    Transwarmer Infant Transport MattressCatalogue number: 20421All batchesOrder codes: BPOD2-TRANS06 / BPOD2-NEON03ARTG number: 221364
  • Manufacturer
    Ferno Australia Pty Ltd

Manufacturer

Ferno Australia Pty Ltd