The Recall Desk

FDA (Devices) recall action 63314

Mindray DS USA, Inc. d.b.a. Mindray North America recalled 2 products on 2012-11-28

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-11-28
Critical
0
Units
—

Why these products were recalled

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.

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.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2012-11-28

    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.

    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
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2012-11-28

    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.

    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
    Category
    Distribution
    1 state