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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-0291-2013
Recall Event ID 63314
510(K)Number K102471 
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product Mindray A5 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 0631F-01000-00
Various serial numbers

0631F-01000-00 EJ-1A001411
0631F-01000-00 EJ-1A001426
0631F-01000-00 EJ-1A001431
0631F-01000-00 EJ-1A001439
0631F-01000-00 EJ-1A001443
0631F-01000-00 EJ-1C001577
0631F-01000-00 EJ-1C001592
0631F-01000-00 EJ-1C001593
0631F-01000-00 EJ-1C001622
0631F-01000-00 EJ-1A001469
0631F-01000-00 EJ-1A001416
0631F-01000-00 EJ-1A001423
0631F-01000-00 EJ-1B001497
0631F-01000-00 EJ-1B001519
0631F-01000-00 EJ-1B001524
0631F-01000-00 EJ-1B001538
0631F-01000-00 EJ-1B001544
0631F-01000-00 EJ-1B001546
0631F-01000-00 EJ-1B001549
0631F-01000-00 EJ-1B001550
0631F-01000-00 EJ-1C001572
0631F-01000-00 EJ-1C001617
0631F-01000-00 EJ-22001684
0631F-01000-00 EJ-1B001540
0631F-01000-00 EJ-1B001548
0631F-01000-00 EJ-21001634
0631F-01000-00 EJ-21001641
0631F-01000-00 EJ-21001642
0631F-01000-00 EJ-21001644
0631F-01000-00 EJ-21001650
0631F-01000-00 EJ-21001643
0631F-01000-00 EJ-21001654
0631F-01000-00 EJ-22001704
0631F-01000-00 EJ-23001760
0631F-01000-00 EJ-23001765
0631F-01000-00 EJ-23001775
0631F-01000-00 EJ-1A001437
0631F-01000-00 EJ-1A001445
0631F-01000-00 EJ-22001710
0631F-01000-00 EJ-22001724
0631F-01000-00 EJ-22001743
0631F-01000-00 EJ-1A001418
0631F-01000-00 EJ-1B001511
0631F-01000-00 EJ-23001764
0631F-01000-00 EJ-23001768
0631F-01000-00 EJ-23001769
0631F-01000-00 EJ-23001779
0631F-01000-00 EJ-23001792
0631F-01000-00 EJ-22001696
0631F-01000-00 EJ-22001701
0631F-01000-00 EJ-22001705
0631F-01000-00 EJ-22001707
0631F-01000-00 EJ-22001723
0631F-01000-00 EJ-1C001573
0631F-01000-00 EJ-1C001589
0631F-01000-00 EJ-1C001590
0631F-01000-00 EJ-1C001599
0631F-01000-00 EJ-1C001610
0631F-01000-00 EJ-1C001619
0631F-01000-00 EJ-21001667
0631F-01000-00 EJ-22001679
0631F-01000-00 EJ-22001686
0631F-01000-00 EJ-22001688
0631F-01000-00 EJ-22001721
0631F-01000-00 EJ-15001187
0631F-01000-00 EJ-1A001420
0631F-01000-00 EJ-22001699
0631F-01000-00 EJ-1B001512
0631F-01000-00 EJ-1A001459
0631F-01000-00 EJ-21001635
0631F-01000-00 EJ-21001636
0631F-01000-00 EJ-21001637
0631F-01000-00 EJ-21001658
0631F-01000-00 EJ-22001681
0631F-01000-00 EJ-22001692
0631F-01000-00 EJ-22001693
0631F-01000-00 EJ-22001698
0631F-01000-00 EJ-22001700
0631F-01000-00 EJ-22001703
0631F-01000-00 EJ-22001712
0631F-01000-00 EJ-22001734
0631F-01000-00 EJ-22001741
0631F-01000-00 EJ-1A001449
0631F-01000-00 EJ-1A001471
0631F-01000-00 EJ-1A001478
0631F-01000-00 EJ-1A001479
0631F-01000-00 EJ-1A001440
0631F-01000-00 EJ-1C001585
0631F-01000-00 EJ-1A001473
0631F-01000-00 EJ-1A001438
0631F-01000-00 EJ-1A001442
0631F-01000-00 EJ-1A001456
0631F-01000-00 EJ-1A001474
0631F-01000-00 EJ-1A001463
0631F-01000-00 EJ-1B001559
0631F-01000-00 EJ-1B001564
0631F-01000-00 EJ-1B001496
0631F-01000-00 EJ-1A001446
0631F-01000-00 EJ-23001757
0631F-01000-00 EJ-1A001421
0631F-01000-00 EJ-1A001424
0631F-01000-00 EJ-23001753
0631F-01000-00 EJ-1A001462
0631F-01000-00 EJ-1A001480
0631F-01000-00 EJ-1A001484
0631F-01000-00 EJ-21001657
0631F-01000-00 EJ-21001662
0631F-01000-00 EJ-21001670
0631F-01000-00 EJ-22001675
0631F-01000-00 EJ-22001676
0631F-01000-00 EJ-22001689
0631F-01000-00 EJ-22001694
0631F-01000-00 EJ-22001697
0631F-01000-00 EJ-22001702
0631F-01000-00 EJ-22001708
0631F-01000-00 EJ-22001713
0631F-01000-00 EJ-22001716
0631F-01000-00 EJ-22001717
0631F-01000-00 EJ-22001718
0631F-01000-00 EJ-22001720
0631F-01000-00 EJ-22001722
0631F-01000-00 EJ-22001727
0631F-01000-00 EJ-22001736
0631F-01000-00 EJ-22001740
0631F-01000-00 EJ-23001762
0631F-01000-00 EJ-23001778
0631F-01000-00 EJ-23001783
0631F-01000-00 EJ-1B001514
0631F-01000-00 EJ-1B001518
0631F-01000-00 EJ-1B001523
0631F-01000-00 EJ-1B001526
0631F-01000-00 EJ-1C001597
0631F-01000-00 EJ-1C001606
0631F-01000-00 EJ-23001750
0631F-01000-00 EJ-23001767
0631F-01000-00 EJ-23001772
0631F-01000-00 EJ-23001777
0631F-01000-00 EJ-22001732
0631F-01000-00 EJ-22001745
0631F-01000-00 EJ-23001766
0631F-01000-00 EJ-23001773
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 346 units (311 US - 35 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.