Recall Z-0291-2013— Mindray DS USA, Inc. d.b.a. Mindray North America

Name: FDA recall Z-0291-2013
Creator: U.S. Food and Drug Administration
Published: 2012-08-13

Class I · Terminated

Class I FDA medical device recall by Mindray DS USA, Inc. d.b.a. Mindray North America, initiated 2012-08-13, terminated 2013-06-04. It names one FDA 510(k) clearance: K102471. 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.. 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..

Recalling firm: Mindray DS USA, Inc. d.b.a. Mindray North America
Classification: Class I
Status: Terminated
Initiated: 2012-08-13
Terminated: 2013-06-04
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K102471 — AS3700 ANESTHSIA DELIVERY SYSTEMMindray DS USA, Inc.·cleared 2011-02-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.