Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Tianjin Grand Paper Industrial Co., Ltd ULTRASOUND GEL

25 Nov 2019

It has come to our attention that the Hospital Authority has raised a medical device safety issue concerning ULTRASOUND GEL, manufactured by Tianjin Grand Paper Industrial Co., Ltd. The affected products are identified as follows:

The affected product is an ultrasound gel applicable to all external ultrasound procedure. According to the information, a microbial contamination, Burkolderia Cepacia complex, has been identified in the affected products.

Burkolderia Cepacia complex is a group of bacteria, which are commonly found in water, soil, and moist environments. Burkolderia Cepacia is generally not pathogenic to healthy person. However, it is a known cause of infections in hospitalized patients. Patients who have certain health problems like weakened immune system, especially immune-compromised patients or in neonatal care, or chronic lung diseases are at higher risk of infection.

According to the local suppliers, the affected products are distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 25 November 2019

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