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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 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
Premarket Notification
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/
Manufacturer
Mindray DS USA, Inc. d.b.a. Mindray North America
800 MacArthur Blvd.
Mahwah, New Jersey 07430
For Additional Information Contact Ms. Diane Arpino
201-995-8407
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
DESIGN: 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.
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