CanadaThe recall affects the Monnal™ T60 Ventilator (model/catalogue number KA017115) and the Expiratory Valve Monnal EVA V2 (model/catalogue number KY732991); the valve is the second-generation expiratory valve used on Monnal T60/T60 Advanced ventilators. The EVA V2 can lead to under-delivery of volumes in child/infant patients because of poor membrane sealing; no patient incidents were reported and the issue was detected during tests, so the company is replacing these valves with the first generation to prevent hypoventilation. Contact the manufacturer for additional information.
What's being recalled
Companies: Air Liquide Medical Systems, 6 Rue Georges Besse, Antony, France, 92182.
How to identify it
Affected products: Monnal™ T60 Ventilator; Lot or serial number: Not applicable.; Model or catalogue number: KA017115
Affected products: Expiratory Valve Monnal EVA V2; Lot or serial number: Not applicable.; Model or catalogue number: KY732991
The hazard
The Monnal EVA V2 (2nd generation - expiratory valve) used on Monnal T60/T60 Advanced ventilators can lead to under-delivery of volumes in "child/infant" patients due to poor membrane sealing. No patient incidents have been reported; the detection occurred during tests. Air liquide medical systems is recalling these valves to replace them with the first generation to prevent the risk of hypoventilation.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)