When the system’s CO2 absorbent canister gasket is improperly seated the system may leak gas, which may be caught during startup testing, the company noted. Should a leak be present the absorbent canister can be unlocked and locked again to reseat the gasket.
The A3 and A5 units can continue to be used, but the users should confirm proper seating of the canister gasket before use or after CO2 absorbent is changed, Mindray warned.
The affected canister gaskets were shipped between May 31, 2011 and July 15, 2012 in the U.S., Latin America and Australia. Mindray notified the customers of the recall by letter in August, and about 70% of units have been corrected so far by a replacement of the canister gasket, according to the press release.
There were no reports of injuries in this recall, and Mindray has kept the FDA apprised of the issue. Customers may report any incidents to the FDA’s MedWatch adverse events program online, by mail or fax.
Heidi Dohse was diagnosed with a rare arrhythmia in 1982 and has been 100% pacemaker dependent for over 30 years. With the help of wearable devices, she has been able to pursue her dream to become a competitive cyclist.
You can hear her story and more when you register for DeviceTalks Boston, October 8-10.
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