PlainRecalls
FDA Devices Moderate Class II Terminated

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)

Reported: September 7, 2016 Initiated: June 15, 2016 #Z-2689-2016

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.

Details

Units Affected
167 units (165 units - US) and (2 units - International)
Distribution
US Nationwide Distribution to AL, MA, MD, MN, MO, NE, NJ, OK, OR, PA and VA; and Canada
Location
Mahwah, NJ

Frequently Asked Questions

What product 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). Recalled by Mindray DS USA, Inc. dba Mindray North America. Units affected: 167 units (165 units - US) and (2 units - International).
Why was this product recalled?
Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 7, 2016. Severity: Moderate. Recall number: Z-2689-2016.