Recall Z-2689-2016— Mindray DS USA, Inc. dba Mindray North America

Name: FDA recall Z-2689-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-15

Class II · Terminated

Class II FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2016-06-15, terminated 2017-03-28. It names one FDA 510(k) clearance: K151954. Product: A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. Part numbers 0632F-PA0000X (US domestic) and 0632B-00014 (international). Reason: Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System..

Recalling firm: Mindray DS USA, Inc. dba Mindray North America
Classification: Class II
Status: Terminated
Initiated: 2016-06-15
Terminated: 2017-03-28
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K151954 — A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.·cleared 2015-10-27

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

A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. Part numbers 0632F-PA0000X (US domestic) and 0632B-00014 (international)

Reason for recall

Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System.

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