Mindray A5 Anesthesia Delivery System Recalled for Potential System Leak
Mindray is recalling A5 Anesthesia Delivery Systems due to a potential system leak caused by a carbon dioxide absorber canister gasket issue.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential system leak that could affect patient safety, but the source text does not report any injuries, illnesses, or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Mindray DS USA, Inc. is recalling 346 units of the Mindray A5 Anesthesia Delivery System. The recall involves 311 units in the United States and 35 units in foreign countries, including Australia, Chile, Colombia, and Venezuela. The devices are used to administer general inhalation anesthetics and maintain patient ventilation.
The recall was initiated because Mindray identified a potential for a system leak resulting from an issue with the carbon dioxide absorber canister gasket. The company notes that this potential leak will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case.
The recalled product
- Product
- Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilati
- Hazard
Distribution
Part of a larger recall action
This product is one of 2 recalled by Mindray DS USA, Inc. d.b.a. Mindray North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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