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)
Recall
- Recall Number
- Z-2689-2016
- Event Number
- 74758
- Firm
- Mindray DS USA, Inc. dba Mindray North America
- FEI Number
- 2221819
- Product Code
- BSZ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- June 15, 2016
- Terminated
- March 28, 2017
- Address
- 800 Macarthur Blvd, Mahwah, NJ, 07430-2001
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)
Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System.
Mindray sent via certified mail with return receipt a recall letter dated June 15, 2016 to their affected customers. Mindray will replace the gasket on all e-size cylinder yokes on the affected A7 systems. Customer was instructed to contact their local Mindray Service Representative to arrange for this replacement. Customers can continue to use their A7 system while awaiting the replacement of the gasket(s). Customers can contact Ms. Diane Arpino, Director, Quality Operations and Regulatory Affairs via email to: [email protected] or via telephone to: (201)995-8407
US Nationwide Distribution to AL, MA, MD, MN, MO, NE, NJ, OK, OR, PA and VA; and Canada
167 units (165 units - US) and (2 units - International)