Felton Grimwade & Bosisto’s Pty Ltd is recalling the below batches of Euky Bear Warm Steam Vaporiser - Humidifier because the enclosed heating element can overheat.
If you do not turn off the device after steaming has stopped, the base of the blue heating module may overheat and disintegrate, producing smoke and fumes. The instructions for use and warning labels on the device state the device should be turned off after steaming has stopped.
ARTG No. | Batch No. |
---|---|
297553 | 230301
231101
A231101
B231101 |
No other batches of Euky Bear (Warm Steam) Vaporiser are affected by this problem.
What is the problem?
Euky Bear Warm Steam Vaporiser- Humidifier contains a blue heating module made of a particular polymer.
The device must be turned off at the power point after steaming has stopped to allow it to cool. If this doesn’t happen, the base of the blue heating module may overheat and disintegrate producing smoke and fumes. If the heating module finger is exposed, this could cause burns to the user.
What should I do?
If you have purchased a Euky Bear (Warm Steam) Vaporiser and it is labelled with one of the batch numbers above, stop using your device and contact eukybear@fgb.com.au to arrange a replacement. Alternatively, you may return it to the place of purchase for a refund.
The batch number is on the base of the box or the underside of the blue heating module (next to the power cord). See the pictures below.
No alternative stock is currently available, but it is expected to be available from December 2023. Consumers will be offered an equivalent replacement in the first instance.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.