FDA Issues Class 1 Recall of Anesthesia Devices

November 30, 2012 — The U.S. Food and Drug Administration (FDA) and Mindray Medical International have initiated a voluntary Class 1 recall of the A3 and A5 Anesthesia Delivery System due to a potential system leak from improper sealing of the CO2 absorbent canister gasket. There are no reports of injuries linked to this recall, but the defect could potentially cause serious injury to patients or caregivers.

Severe anesthesia injuries can occur when a patient is not administered the correct amount of anesthetic before a surgery. The leak could cause patients to be under-anesthetized before their surgery. Patients my experience pain, but because they are also given a paralyzing drug to prevent motion during surgery, they may be unable to communicate the problem with the physician.

According to the FDA, serious injuries that could occur due to the defect include:

“…interruption of or inadequate patient anesthesia and ventilation, temporary or permanent patient injury, or death. … The gasket leak could also cause injury to bystanders and operating room personnel due to exposure from leaking anesthesia gases.”

The FDA also recommends that facilities with the device should consider having backup equipment to maintain patient ventilation just in case the device fails due to the gasket leak.

The recall of the Mindray A3 and A5 Anesthesia Delivery Systems was initiated in August 2012. The affected products were manufactured from May 2011 until March 2012, and distributed until July 15, 2012. Most customers who owned the device have been contacted and more than 70% of the devices have been fixed.

Mindray first became aware of the defect when a customer noticed a “step” in the gasket surface. Customers will likely notice the defect when they test the machine before each use.

Class 1 recalls are reserved for products or devices that have a good probability of causing severe injury or death. These recalls are the most serious and urgent type of recall the FDA can initiate.

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