Recall Z-0290-2013 ยท BSZ Gas-Machine, Anesthesia
Mindray DS USA, Inc. d.b.a. Mindray North America
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 ventilation.
| Date | Nov 16, 2012 (initiated Aug 13, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | The firm, Mindray DS USA Inc., sent an "URGENT: A3/A5 ANESTHESIA DELIVERY SYSTEM CORRECTIVE ACTION" letter dated August 13, 2012 to their customers via Certified Mail return receipt requested. The letter described the product, problem and actions to be taken. The customers were instructed to route this letter to all potential uses of the product within their facility; increase fresh gas flow, should the leak occur during use, to compensate for any pressure loss resulting from the leak; alternatively, the absorber canister may be unlocked and locked again to reseat the gasket and verify that |
| Quantity | 69 units (61 US - 8 Foreign) |
| Distribution | Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Chile, Colombia, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102471 | AS3700 ANESTHSIA DELIVERY SYSTEM Mindray DS USA, Inc., Feb 11, 2011 |