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Health Canada Medical devices

Ventstar Breathing Circuits

Issued April 4, 2023
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
Hazard description
Performance
Product
Product name
Ventstar Breathing Circuits
Reference
ID
RA-73450