| Date Posted |
November 16, 2012 |
| Recall Number |
Z-0291-2013 |
| 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
0631F-01000-00 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
0631F-01000-00 EJ-23001763
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
0631F-01000-00 EJ-1C001613
0631F-01000-00 EJ-1B001541
0631F-01000-00 EJ-1C001571
0631F-01000-00 EJ-1C001578
0631F-01000-00 EJ-1C001586
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
0631F-01000-00 EJ-23001785
0631F-01000-00 EJ-22001729
0631F-01000-00 EJ-22001739
0631F-01000-00 EJ-23001746
0631F-01000-00 EJ-23001748
0631F-01000-00 EJ-23001754
0631F-01000-00 EJ-23001758
0631F-01000-00 EJ-1A001413
0631F-01000-00 EJ-1A001417
0631F-01000-00 EJ-1A001458
0631F-01000-00 EJ-1A001485
0631F-01000-00 EJ-1B001520
0631F-01000-00 EJ-21001645
0631F-01000-00 EJ-21001663
0631F-01000-00 EJ-21001665
0631F-01000-00 EJ-21001666
0631F-01000-00 EJ-1B001491
0631F-01000-00 EJ-1B001494
0631F-01000-00 EJ-1B001503
0631F-01000-00 EJ-1B001508
0631F-01000-00 EJ-1B001513
0631F-01000-00 EJ-1B001522
0631F-01000-00 EJ-1B001525
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
0631F-01000-00 EJ-21001661
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
0631F-01000-00 EJ-1B001560
0631F-01000-00 EJ-1C001587
0631F-01000-00 EJ-1C001595
0631F-01000-00 EJ-1B001563
0631F-01000-00 EJ-1C001568
0631F-01000-00 EJ-1C001579
0631F-01000-00 EJ-22001687
0631F-01000-00 EJ-1A001481
0631F-01000-00 EJ-1A001451
0631F-01000-00 EJ-1A001460
0631F-01000-00 EJ-1A001461
0631F-01000-00 EJ-1A001470
0631F-01000-00 EJ-1A001428
0631F-01000-00 EJ-1A001433
0631F-01000-00 EJ-1B001501
0631F-01000-00 EJ-1B001505
0631F-01000-00 EJ-1B001509
0631F-01000-00 EJ-22001691
0631F-01000-00 EJ-22001695
0631F-01000-00 EJ-22001706
0631F-01000-00 EJ-22001719
0631F-01000-00 EJ-22001726
0631F-01000-00 EJ-22001728
0631F-01000-00 EJ-22001731
0631F-01000-00 EJ-22001733
0631F-01000-00 EJ-22001735
0631F-01000-00 EJ-22001738
|
Recalling Firm/
Manufacturer |
Mindray DS USA, Inc. d.b.a. Mindray North America
800 MacArthur Blvd.
Mahwah, New Jersey 07430 |
| Consumer Instructions |
Contact the recalling firm for information |
| For Additional Information Contact |
Ms. Diane Arpino
800-2882121
|
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.
|
| 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. |
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