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Mindray DS USA, Inc. d.b.a. Mindray North America recalls Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, N
Recalled November 28, 2012 · FDA recall Z-0291-2013 · Mindray DS USA, Inc.
Hazard
Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister gasket 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. · FDA Class I
Units
346 units (311 US - 35 Foreign)
Sold at
Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Chile, Colombia, and Venezuela.
Description
Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister gasket 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.
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 ventilation.
Manufacturer(s)
Mindray DS USA, Inc. d.b.a. Mindray North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →