Medical device manufacturer, USF Healthcare, has issued a medical device safety alert concerning its UNISEPTA FOAM 2 [Packaging: A) 12x750ML; B) 1X750ML; C) 2X5L; Article Code: A) 2458241_L3, 2458241GM; B) 2458953; C) 2458539_L3]
A microbial contamination, Burkolderia Cepacia, has been identified and localized in the manufacturing process of the affected product, which has resulted in a potential bacterial contamination to the batches produced.
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, the bacteria, if present in the product, dies two and a half minutes after product use on surfaces.
According to the manufacturer, 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 immune-compromised 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. The manufacturer has introduced additional hygiene security protocols, which means that all our medical devices manufactured and delivered from the Sainghin-en-Mélantois plant will have successfully passed the test protocols.
For precautionary reasons, customers are asked to stop immediately using, block and isolate the affected product, as there is a risk they may be contaminated. Product recall is on-going.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 14 November 2019