Medical device manufacturer, USF Healthcare, has issued a medical device safety alert concerning its disinfecting wipes. The products are identified as follow:
UNISEPTA FOAM 2 WIPES
A microbial contamination source (Gram-negative Burkholderia cepacia) has been identified and localized in an outsourced manufacturing process and has brought a potential bacterial contamination to some batches of manufactured wipes.
According to the manufacturer, in case of contamination triggered by contaminated wipes, immunocompromised patients would be at greater risk of infection (pneumonia). Globally, the risk assessment for potential health hazard linked to the use of those wipes results in low risk for the patient and the user.
Corrective actions to eliminate the contamination source have been implemented and are being closely monitored.
Customers are advised not to use any longer the affected products.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 28 January 2019