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Mindray Anesthesia Delivery System Recalled Due to Leak Risk


Mindray’s A3/A5 Anesthesia Delivery System was recalled due to the possibility of a system leak resulting from improper seating of the CO2 absorbent canister gasket. Should a system leak occur during use, fresh gas flow may be increased to compensate for any pressure loss resulting from the leak while the absorbent canister is unlocked and locked again to reseat the gasket. If the CO2 absorbent canister gasket is improperly seated, however, a potential leak will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case, at which time the absorbent canister can be unlocked and locked again to reseat the gasket.

 

The canister gasket subject to this recall may be identified by presence of a small “step” in the gasket surface. A3/A5 units with this gasket may continue to be used. The proper seating of the canister gasket should be confirmed prior to use and after CO2 absorbent is changed.

 

Units with the affected canister gaskets were shipped between May 31, 2011 and July 15, 2012 in the United States, Latin America and Australia.

 

See the Recall

 

 

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