Mindray DS USA, Inc. has Initiated a Voluntary Recall Affecting the
A3/A5 Anesthesia Delivery System
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.
- Online: http://www.fda.gov/medwatch/report.htm
- Regular mail: use postage-paid, pre-addressed Form FDA3500
available at http://www.fda.gov/MedWatch/getforms.htm
- Fax: 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
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