Mindray A3, A5 Anesthesia Delivery System Recall Designated as Class I
Federal health regulators fear that two anesthesia delivery system devices recalled in August could pose a serious risk for patients and healthcare professionals, categorizing the action as a Class I Medical Device Recall.
A Mindray Anesthesia Delivery System recall was issued following reports of carbon dioxide leaks caused by the improper seating of the CO2 absorbent canister gaskets.
Last week the FDA determined that the action constitutes a Class I recall, indicating that anesthesia delivery systems with a gasket leak could cause inadequate patient anesthesia or pose a risk for operating room personnel due to exposure from leaking anesthesia gases.
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A Class I recall designation suggests that the agency has determined that the problem has a high probability of causing severe or fatal injuries and complications.
The recalled products include the Mindray A3 and A5 models, which were distributed from May 31, 2011 through July 15, 2012 in the USA, Puerto Rico, Australia, Chile, Colombia, and Venezuela by Mindray DS USA Inc. of Mahwah, New Jersey. Approximately 69 units of the A3 model were recalled including 61 in the US and 346 units of the A5 model including 311 in the US.
The devices are intended to administer anesthesia and maintain breathing during surgery for both pediatric and adult patients. However, due to an improper seating of a gas canister, the systems may cause carbon dioxide leaks.
Both A3 and A5 models have an Automatic Circuit Leak and Compliance Test as well as a Manual Leak Test that are recommended before each use to identify if the device has any leaks or malfunctions.
No injuries related to the devices have been reported but Mindray has announced that health care professionals should have backup equipment to maintain patient ventilation in the event the device fails.
Customers with questions or who have not already arranged for a replacement can call Mindray at (800) 288-2121.
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