Ventstar Breathing Circuits

Issue

During global market surveillance activities, manufacturer became aware of cases in which glued connections of the breathing circuits became loose either before or during the ventilation process resulting in partial or complete detachment of components such as watertrap, y-piece or hose connector. There were no reports of any adverse impact on the health of the patients involved. Investigations have identified that the adhesive joint did not conform to specification due to a manufacturing error. If system components become loose and/or detach from the hose during use, ventilation of the patient will be restricted. Recall start date: March 22, 2023

What you should do

• Contact the manufacturer if you require additional information.