USF Healthcare SA USF-FSCA-002 - UNISEPTA FOAM 2

We have identified that you received products in the above table, and we are recalling all batches (Annex II) as they do not comply with our quality expectations. They may contain the opportunistic environmental microorganism Burkholderia Cepacia.

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. We have introduced additional hygiene security protocols which means that all our medical devices manufactured and delivered from our Sainghin-en-Mélantois plant will have successfully passed the test protocols.

For precautionary reasons, we ask that you stop immediately using the recalled products that you may have in stock, as there is a risk they may be contaminated.