Navigation Links
Mindray DS USA, Inc. has Initiated a Voluntary Recall Affecting the A3/A5 Anesthesia Delivery System
Date:11/13/2012

MAHWAH, N.J., Nov. 14, 2012 /PRNewswire-FirstCall/ -- Mindray Medical International Limited (NYSE: MR), a leading developer, manufacturer and marketer of medical devices worldwide, has initiated a voluntary recall affecting the A3/A5 Anesthesia Delivery System.  Mindray has initiated this recall due to the possibility of a system leak resulting from improper seating of the CO2 absorbent canister gasket.

Should a system leak occur during use, fresh gas flow may be increased to compensate for any pressure loss resulting from the leak while the absorbent canister is unlocked and locked again to reseat the gasket. If the CO2 absorbent canister gasket is improperly seated, however, a potential leak 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, at which time the absorbent canister can be unlocked and locked again to reseat the gasket.

The canister gasket subject to this recall may be identified by presence of a small "step" in the gasket surface.  A3/A5 units with this gasket may continue to be used.  The proper seating of the canister gasket should be confirmed prior to use and after CO2 absorbent is changed.

Customers who have a system(s) subject to this recall were notified by on August 8, 2012 by letter via US Postal Mail, return receipt required. To date, approximately 70% of units affected by this action have been corrected.  The issue is corrected through a replacement of the canister gasket by a Mindray Service or authorized representative.

Units with the affected canister gaskets were shipped between May 31, 2011 and July 15, 2012 in the United States, Latin America and Australia.

There have been no reports of injuries associated with this issue. Mindray became aware of the issue when a system leak was reported by a customer.  The cause of the leak was determined to be the result of an improperly seated canister gasket.

Mindray has advised the US Food and Drug Administration of this voluntary recall.

Any adverse reactions or quality problems experienced with the use of this product may be reported to the U.S. Food and Drug Administration's (FDA) MedWatch Adverse Events Program either online, by regular mail or by fax.

Consumers who have questions should call:

Mindray North America at 1-800-288-2121 ext. 5050, Monday-Friday, 8:30-5:30, EST

About Mindray

We are a leading developer, manufacturer and marketer of medical devices worldwide. We maintain our global headquarters in Shenzhen, China, U.S. headquarters in Mahwah, New Jersey and multiple sales offices in major international markets. From our main manufacturing and engineering base in China, we supply through our worldwide distribution network a broad range of products across three primary business segments, namely patient monitoring and life support, in-vitro diagnostic, and medical imaging systems. For more information, please visit http://ir.mindray.com.

For investor and media inquiries please contact:

In the U.S:
Hoki Luk
Western Bridge, LLC
Tel:      +1-646-808-9150      
Email:  hoki.luk@westernbridgegroup.com

In China: 
Cathy Gao
Mindray Medical International Limited
Tel:      +86-755-8188-8023      
Email:  cathy.gao@mindray.com


'/>"/>
SOURCE Mindray Medical International Limited
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Mindray Medical Announces Top Management Change
2. Mindray Medical to Participate in MEDICA 2012 in Dusseldorf, Germany
3. Mindray Announces Second Quarter 2012 Financial Results
4. Mindray to Report Second Quarter 2012 Financial Results on August 6, 2012
5. Mindray Medical Completes Acquisition of Dragonbios Orthopedics Business
6. Mindray Medical to Present at AACC Clinical Lab Expo 2012
7. Mindray Announces First Quarter 2012 Financial Results
8. Mindray Medical to Acquire Controlling Stake in Hangzhou Optcla Medical Instrument
9. Mindray Files Annual Report on Form 20-F with the U.S. Securities and Exchange Commission
10. ESTEVE Announces Publication of Key Preclinical Data for a Novel Oral, First-in-class New Chemical Entity (NCE) Sigma-1 Receptor Antagonist (E-52862), that has Completed Phase I and Initiated its Phase II Clinical Trial Program
11. Zi Xiu Tang Success, LLC Issues Voluntary Nationwide Recall of Classic Zi Xiu Tang Bee Pollen Capsules and Ultimate Formula Capsules due to Undeclared Sibutramine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... 2016   Bay Area Lyme Foundation , ... Center for Tick Borne Illness , Harvard Medical ... Hacking Medicine, University of California, Berkeley, and the ... five finalists of Lyme Innovation , the ... 100 scientists, clinicians, researchers, entrepreneurs, and investors from ...
(Date:6/24/2016)... 2016 The Academy of Managed Care Pharmacy ... that would allow biopharmaceutical companies to more easily share ... formulary and coverage decisions, a move that addresses the ... The recommendations address restrictions in the sharing ... drug label, a prohibition that hinders decision makers from ...
(Date:6/24/2016)... , June 24, 2016 Research ... World Market for Companion Diagnostic Tests" report to their ... Market for Companion Diagnostics The World Market ... and personalized medicine diagnostics. Market analysis in the report includes ... Test Market (In Vitro Diagnostic Kits) by Region (N. America, ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... ... strategic partnership with Connance, a healthcare industry leader providing predictive analytics to ... technology combine to provide health systems, hospitals and ambulatory surgical centers with ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, ... editors can give their videos a whole new perspective by using the title ... Pixel Film Studios. , ProSlice Levels contains over 30 Different presets to choose ...
(Date:6/25/2016)... ... 25, 2016 , ... Austin residents seeking Mohs surgery services, can now turn ... to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization ... selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. ... from injury. Recently, he has implemented orthobiologic procedures as a method for treating ... one of the first doctors to perform the treatment. Orthobiologics are substances that ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World ... with chronic pain and the benefits of holistic treatments, Serenity Recovery Center ... with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the ...
Breaking Medicine News(10 mins):