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Mindray DS USA Recalls A3/A5 Anesthesia Delivery System

November 14, 2012 05:36pm  
Mindray DS USA Recalls A3/A5 Anesthesia Delivery System

On November 14, 2012, the Food and Drug Administration (FDA) announced a recall that could affect a huge percentage of the medical industry.  Mindray Medical International Limited issued a voluntary recall of the A3/A5 Anesthesia Delivery System because the improper seating of the CO2 absorbent canister gasket can cause the system to leak.  

Mindray is one of the leading developers, manufacturers, and distributors of medical equipment around the world.  

The FDA reports that a system leak will require fresh gas flow to increase in order to compensate for the pressure loss.  A leak can likely be found in the case of the CO2 absorbent canister gasket being seating incorrectly if the Automatic Circuit Leak and Compliance Test is done before the startup and the Manual Leak Test is performed before use.  If a leak is apparent, the canister can be unlocked, repositioned, and locked again.  

The canister gasket is undergoing a voluntary recall because there may be what the FDA calls a small “step” on the gasket’s surface.  The A3/A5 units and gaskets can still be used if the medical professional determines the canister is correctly positioned before use and after the CO2 absorbent is changed.  

Notices of the recall were sent to affected customers around August 8, 2012 by mail.  Since then, about 70 percent of the affected units have been repaired after Mindray replaced the canister gaskets.  The units were shipped to the United States, Latin America, and Australia between May 31, 2011 and July 15, 2012.  

The FDA has not received any injuries resulting from the canisters leaking at this point.  If any adverse reactions occur, the problems must be reported to the FDA’s MedWatch Adverse Events Program.  If you need to contact Mindray in the United States, call Hoki Luk with the Western Bridge, LLC at 1-646-808-9150.  

Source: U.S. Food and Drug Administration


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