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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 000-00 EJ-23001780
0631F-01000-00 EJ-23001782
0631F-01000-00 EJ-23001786
0631F-01000-00 EJ-21001656
0631F-01000-00 EJ-21001660
0631F-01000-00 EJ-23001755
0631F-01000-00 EJ-23001761
0631F-01000-00 EJ-1A001435
0631F-01000-00 EJ-22001682
0631F-01000-00 EJ-22001730
0631F-01000-00 EJ-22001737
0631F-01000-00 EJ-23001747
0631F-01000-00 EJ-23001751
0631F-01000-00 EJ-23001756
0631F-01000-00 EJ-1A001447
0631F-01000-00 EJ-1A001450
0631F-01000-00 EJ-1A001455
0631F-01000-00 EJ-22001711
0631F-01000-00 EJ-1A001434
0631F-01000-00 EJ-1B001532
0631F-01000-00 EJ-1B001533
0631F-01000-00 EJ-1A001419
0631F-01000-00 EJ-1B001493
0631F-01000-00 EJ-1B001507
0631F-01000-00 EJ-1B001528
0631F-01000-00 EJ-1A001444
0631F-01000-00 EJ-1B001502
0631F-01000-00 EJ-1A001453
0631F-01000-00 EJ-1A001467
0631F-01000-00 EJ-1B001498
0631F-01000-00 EJ-1B001506
0631F-01000-00 EJ-23001749
0631F-01000-00 EJ-23001759
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0631F-01000-00 EJ-23001771
0631F-01000-00 EJ-23001784
0631F-01000-00 EJ-1C001574
0631F-01000-00 EJ-1C001580
0631F-01000-00 EJ-1C001588
0631F-01000-00 EJ-1C001591
0631F-01000-00 EJ-1C001594
0631F-01000-00 EJ-1C001598
0631F-01000-00 EJ-22001714
0631F-01000-00 EJ-23001774
0631F-01000-00 EJ-1A001412
0631F-01000-00 EJ-1A001422
0631F-01000-00 EJ-1A001425
0631F-01000-00 EJ-1C001570
0631F-01000-00 EJ-1C001611
0631F-01000-00 EJ-1C001612
0631F-01000-00 EJ-1B001555
0631F-01000-00 EJ-1B001556
0631F-01000-00 EJ-1C001566
0631F-01000-00 EJ-1C001567
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0631F-01000-00 EJ-1C001571
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0631F-01000-00 EJ-1C001596
0631F-01000-00 EJ-1C001607
0631F-01000-00 EJ-1C001609
0631F-01000-00 EJ-1C001614
0631F-01000-00 EJ-1C001615
0631F-01000-00 EJ-1C001616
0631F-01000-00 EJ-1C001618
0631F-01000-00 EJ-1C001620
0631F-01000-00 EJ-1C001621
0631F-01000-00 EJ-1C001623
0631F-01000-00 EJ-1C001626
0631F-01000-00 EJ-1C001628
0631F-01000-00 EJ-1C001629
0631F-01000-00 EJ-1C001630
0631F-01000-00 EJ-21001669
0631F-01000-00 EJ-21001671
0631F-01000-00 EJ-21001672
0631F-01000-00 EJ-1A001430
0631F-01000-00 EJ-1A001441
0631F-01000-00 EJ-23001770
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0631F-01000-00 EJ-22001729
0631F-01000-00 EJ-22001739
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0631F-01000-00 EJ-23001748
0631F-01000-00 EJ-23001754
0631F-01000-00 EJ-23001758
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0631F-01000-00 EJ-1A001458
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0631F-01000-00 EJ-1B001522
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0631F-01000-00 EJ-21001649
0631F-01000-00 EJ-22001680
0631F-01000-00 EJ-22001715
0631F-01000-00 EJ-1A001464
0631F-01000-00 EJ-21001673
0631F-01000-00 EJ-21001674
0631F-01000-00 EJ-1B001529
0631F-01000-00 EJ-1C001627
0631F-01000-00 EJ-21001638
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0631F-01000-00 EJ-21001664
0631F-01000-00 EJ-21001668
0631F-01000-00 EJ-1A001472
0631F-01000-00 EJ-1A001486
0631F-01000-00 EJ-1B001490
0631F-01000-00 EJ-1B001495
0631F-01000-00 EJ-1A001448
0631F-01000-00 EJ-1A001452
0631F-01000-00 EJ-1A001454
0631F-01000-00 EJ-1A001466
0631F-01000-00 EJ-1A001477
0631F-01000-00 EJ-1B001534
0631F-01000-00 EJ-1B001547
0631F-01000-00 EJ-1C001575
0631F-01000-00 EJ-1A001414
0631F-01000-00 EJ-1A001429
0631F-01000-00 EJ-1B001515
0631F-01000-00 EJ-1B001517
0631F-01000-00 EJ-1B001545
0631F-01000-00 EJ-1B001489
0631F-01000-00 EJ-1B001492
0631F-01000-00 EJ-1B001504
0631F-01000-00 EJ-1B001531
0631F-01000-00 EJ-1B001521
0631F-01000-00 EJ-1A001415
0631F-01000-00 EJ-1B001510
0631F-01000-00 EJ-1B001536
0631F-01000-00 EJ-1A001457
0631F-01000-00 EJ-1A001468
0631F-01000-00 EJ-1B001557
0631F-01000-00 EJ-1B001558
0631
Recalling Firm/
Manufacturer
Mindray DS USA, Inc. d.b.a. Mindray North America
800 MacArthur Blvd.
Mahwah NJ 07430
800-2882121
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
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.
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