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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

Product Description Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.
Recall Number Z-0290-2013
Classification Class I
Code Info 0633F-01000-00 Various serial numbers 0633F-01000-00 FA-1A000033 0633F-01000-00 FA-1A000023 0633F-01000-00 FA-21000072 0633F-01000-00 FA-1A000029 0633F-01000-00 FA-21000085 0633F-01000-00 FA-19000011 0633F-01000-00 FA-19000008 0633F-01000-00 FA-19000009 0633F-01000-00 FA-1A000027 0633F-01000-00 FA-1A000047 0633F-01000-00 FA-1A000055 0633F-01000-00 FA-1A000041 0633F-01000-00 FA-1A000053 0633F-01000-00 FA-1B000056 0633F-01000-00 FA-21000080 0633F-01000-00 FA-19000007 0633F-01000-00 FA-19000013 0633F-01000-00 FA-21000066 0633F-01000-00 FA-21000078 0633F-01000-00 FA-19000012 0633F-01000-00 FA-19000017 0633F-01000-00 FA-1A000021 0633F-01000-00 FA-1A000028 0633F-01000-00 FA-1A000038 0633F-01000-00 FA-1A000045 0633F-01000-00 FA-1A000035 0633F-01000-00 FA-1A000037 0633F-01000-00 FA-1A000026 0633F-01000-00 FA-1A000030 0633F-01000-00 FA-1A000048 0633F-01000-00 FA-1A000040 0633F-01000-00 FA-1B000059 0633F-01000-00 FA-1A000034 0633F-01000-00 FA-1A000049 0633F-01000-00 FA-21000062 0633F-01000-00 FA-21000064 0633F-01000-00 FA-21000074 0633F-01000-00 FA-21000082 0633F-01000-00 FA-21000090 0633F-01000-00 FA-1A000022 0633F-01000-00 FA-1A000051 0633F-01000-00 FA-1A000052 0633F-01000-00 FA-1A000042 0633F-01000-00 FA-1A000050 0633F-01000-00 FA-1B000057 0633F-01000-00 FA-1B000061 0633F-01000-00 FA-1A000025 0633F-01000-00 FA-1A000031 0633F-01000-00 FA-1A000036 0633F-01000-00 FA-1A000044 0633F-01000-00 FA-21000076 0633F-01000-00 FA-21000077 0633F-01000-00 FA-21000088 0633F-01000-00 FA-1A000043 0633F-01000-00 FA-1A000032 0633F-01000-00 FA-1A000046 0633F-01000-00 FA-1B000058 0633F-01000-00 FA-1B000060 0633F-01000-00 FA-19000010 0633F-01000-00 FA-19000015 0633F-01000-00 FA-21000086
Product Distributed Qty 69 units (61 US - 8 Foreign)
Reason For Recall Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister gasket 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.

Event Detail

Event Id 63314
Product Type Devices
Status Ongoing
Recalling Firm Mindray DS USA, Inc. d.b.a. Mindray North America
City Mahwah
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Chile, Colombia, and Venezuela.