Mindray Initiates Voluntary Recall Affecting the A3/A5 Anesthesia Delivery System
Mindray Medical (NYSE: MR) has initiated a voluntary recall affecting the A3/A5 Anesthesia Delivery System. Mindray has initiated this recall 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.
Customers who have a system(s) subject to