| Date Initiated by Firm |
August 13, 2012 |
| Date Posted |
November 16, 2012 |
| Recall Status1 |
Terminated 3 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 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 NJ 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 |
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = BSZ and Original Applicant = MINDRAY DS USA, INC.
|
