Mindray DS USA, Inc. has Initiated a Voluntary Recall Affecting the A3/A5 Anesthesia Delivery System

  Mindray DS USA, Inc. has Initiated a Voluntary Recall Affecting the A3/A5
                          Anesthesia Delivery System

PR Newswire

MAHWAH, N.J., Nov. 14, 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 CO[2] 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 CO[2]
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 CO[2] 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.

  oOnline: http://www.fda.gov/medwatch/report.htm
  oRegular mail: use postage-paid, pre-addressed Form FDA3500 available at
    http://www.fda.gov/MedWatch/getforms.htm
  oFax: 1-800-FDA-0178

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 inShenzhen, China, U.S.
headquarters inMahwah, New Jerseyand multiple sales offices in major
international markets. From our main manufacturing and engineering base
inChina, 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 visithttp://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

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

SOURCE Mindray Medical International Limited

Website: http://ir.mindray.com
Website: http://www.fda.gov/medwatch/report.htm
Website: http://www.fda.gov/MedWatch/getforms.htm
 
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