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U.S. Department of Health and Human Services

Class 1 Device Recall A3/A5 Anesthesia Delivery System

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 Class 1 Device Recall A3/A5 Anesthesia Delivery System see related information
Date Posted November 16, 2012
Recall Status1 Terminated on June 04, 2013
Recall Number Z-0290-2013
Recall Event ID 63314
510(K)Number K102471 
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product 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.
Code Information 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
Recalling Firm/
Mindray DS USA, Inc. d.b.a. Mindray North America
800 MacArthur Blvd.
Mahwah NJ 07430
For Additional Information Contact Ms. Diane Arpino
Manufacturer 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.
FDA Determined
Cause 2
Device Design
Action The firm, Mindray DS USA Inc., sent an "URGENT: A3/A5 ANESTHESIA DELIVERY SYSTEM CORRECTIVE ACTION" letter dated August 13, 2012 to their customers via Certified Mail return receipt requested. The letter described the product, problem and actions to be taken. The customers were instructed to route this letter to all potential uses of the product within their facility; increase fresh gas flow, should the leak occur during use, to compensate for any pressure loss resulting from the leak; alternatively, the absorber canister may be unlocked and locked again to reseat the gasket and verify that the canister and gasket are fully seated, a leak test is performed after replacement of the Pre-Pak or loose-fill absorbent and also be performed before each patient use until the canister gaskets are replaced on systems in their facility. A Mindray Representative will replace the canister gasket to correct the issue. If you have any questions or need to arrange for a replacement of the absorber canister gasket on the A3/A5 System(s) in your facility, contact your Mindray Service Representative, at 1-800-288-2121 (Monday-Friday 8:30am-5:30pm). A press release was issued by the firm on 11/14/2012.
Quantity in Commerce 69 units (61 US - 8 Foreign)
Distribution Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Chile, Colombia, and Venezuela.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = MINDRAY DS USA, INC.