FDAFDA · Food and drugs·Recall number Z-0291-2013

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.

Published November 28, 2012 · Recall initiated: August 13, 2012

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Mindray DS USA, Inc. d.b.a. Mindray North America
Distributor: Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Chile, Colombia, and Venezuela.
Lot: 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-01
Risk classification: Class I
Area (FDA): device
Country: United States

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