Mindray DS USA, Inc. dba Mindray North America recalls A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inha…

Recall date

June 15, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2689-2016

FDA classification

Class II

Brand / firm

Mindray DS USA, Inc. dba Mindray North America

Sold / distributed

US Nationwide Distribution to AL, MA, MD, MN, MO, NE, NJ, OK, OR, PA and VA; and Canada

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)