It has come to our attention that the Hospital Authority has raised a medical device safety issue concerning Sky Gel ultrasound gel, manufactured by ISD Meditech Sdn. Bhd. The affected product is identified as follows:
Affected Lots Numbers: UGB20022019, UGC20022019, UGC23022019, UGC25022019 and UGC24062019.
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 five lots of the affected product.
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 19 November 2019