Carbon Dioxide Leaks Lead to A3/A5 Anesthesia Delivery System Recall
Reports of carbon dioxide leaks have led to a recall of Mindray anesthesia systems.
The Mindray A3/A5 Anesthesia Delivery System recall was announced by the FDA on November 14, after the manufacturer received a report suggesting that the device may have a tendency to leak carbon dioxide (CO2). There have been no reports of injury or illness resulting from the defective anesthesia systems.
According to the recall announcement, the leaks are caused by improper seating of the CO2 absorbent canister gasket. When the gasket is improperly seated it will likely be detected during the system’s Automatic Circuit Leak and Compliance Test, which is performed at startup. It will also likely be detected during the Manual Leak Test, which the company recommends be conducted before each use. In these instances the canister can be unlocked and locked again to reseat the gasket, the company advises.
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The company actually began notifying its customers individually of the problem in August and enacting repairs. However only 70% of the systems on the market have been repaired.
The recall affects the A3/A5 Anesthesia Delivery Systems shipped between May 31, 2011 and July 15, 2012 in the U.S., Australia and throughout Latin America. The affected units can be identified by a small “step” in the gasket surface.
Repairs are being conducted by Mindray Service or authorized representatives who replace the canister gasket.
Consumers with questions can contact the company by calling (800) 288-2121 ext. 5050.
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