Mindray A3 Anesthesia Delivery System Recalled for Potential System Leak
Mindray is recalling 69 A3 Anesthesia Delivery Systems due to a potential system leak caused by a carbon dioxide absorber canister gasket issue.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low probability of adverse health consequences. The hazard is a potential leak that is expected to be detected by standard startup and pre-case safety tests, and no injuries or illnesses are reported in the source text.
Plain-English summary
Mindray DS USA, Inc. is recalling 69 units of the Mindray A3 Anesthesia Delivery System. The recall involves 61 units in the United States and 8 units in foreign countries. The affected devices were distributed nationwide in the US, including Puerto Rico, as well as in Australia, Chile, Colombia, and Venezuela.
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.
Healthcare facilities and users should check their inventory for the specific serial numbers listed in the recall notice. If a device is affected, users should follow the instructions provided by Mindray regarding the leak tests and any necessary corrective actions.
The recalled product
- Product
- Mindray A3 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 ventila
- 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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