Medical device manufacturer, Laboratoires Anios, has issued a medical device safety alert concerning its SURFA'SAFE PREMIUM. The affected product distributed in Hong Kong is identified as follows:
The manufacturer informed the affected products do not comply with quality expectations. They may contain the opportunistic environmental microorganism Burkholderia Cepacia.
The products are available in a variety of packaging: foam sprays, diffused foam sprays and dropping bottles. Depending on the indicated application of the products, the risks are different. When using a diffused foam form, the risk is higher for the at-risk population due to possible inhalation exposure. When using the product in a wiping action, the probability of the bacteria infecting the at-risk patient population is less important. Laboratory data indicates that in SURFA'SAFE PREMIUM the bacteria dies two and a half minutes after product use on surfaces.
Burkholderia cepacia poses little medical risk to healthy people. However, it is a known cause of infections in hospitalized patients. Patients who have certain health problems like weakened immune systems, especially immunocompromised patients or in neonatal care, or chronic lung diseases, particularly those with cystic fibrosis, are at higher risk of infection.
Corrective actions to eliminate the contamination source are being implemented and the manufacturer has introduced additional hygiene security protocols.
For precautionary reasons, customers are asked to stop, block and isolate immediately using the affected product. Product recall is on-going.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 5 December 2019