Announcement for the Australian market only

Product Recall:

Blissbaby - Flatus tube, single-use – Lufti Colic Reliever

Bliss Baby is recalling all batches of ARTG 351147 - Flatus tube, single-use – Lufti Colic Reliever, due to insufficient evidence provided to the TGA to support its safe use.

 

 

What is the problem?

BlissBaby did not supply sufficient evidence to the TGA for the safe use of their product, the Lufti Colic Reliever. The product has been cancelled from the Australian Register of Therapeutic Goods (ARTG). 

What are the risks?

As insufficient evidence for the safe use of the device was not provided to the TGA, potential harms and risk cannot be ruled out, so the devices are being recalled.

No adverse events have been reported to date.

What should I do? 

·       Anyone who is concerned in any way about the use of this product should consult their doctor.

·       If you have purchased any Blissbaby - Flatus tube, single-use – Lufti Colic Relievers, do not use them.

·       Contact Blissbaby on info@blissbaby.com.au or call 0421 850 487 to organise a return and refund of the affected product.

Further information

Please contact BlissBaby Australia customer service on info@blissbaby.com.au or call 0421 850 487 for further information.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

We 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.