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FDA · FDA event 93474 · Posted Dec 20, 2023
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.
The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.
| Model | Description | Lot / serial range | Manufactured | Status |
|---|---|---|---|---|
| Z-0549-2024 | Z-0549-2024 | UDI-DI 00811505030320 Serial numbers 2213800363 2213800343 2213800328 2213800222 2213800173 2212201120 2212201119 2212201118 2212201115 2212201113 2212201111 2212201100 2212201095 2212201093 2212201088 2212201076 2212201074 2212201061 2212201059 2212201046 2212201029 2212201024 2212201003 2212201002 2212200993 2212200990 2212200987 2212200986 2212200982 2212200978 2212200958 2212200952 2212200945 2212200938 2212200929 2212200914 2205900177 2205900176 2205900170 2205900167 2205900158 2205900152 2205900150 2205900143 2205900133 2205900132 2205900128 2205900126 2205900125 2205900113 2205900112 2205900110 2205900109 2205900108 2205900107 2205900106 2205900098 2205900096 2205900094 2205900091 2205900090 2205900074 2205900072 2205900071 2205900067 2205900062 2205900061 2201811620 2201811615 2201811614 2201811605 2118200011 2201811603 2201811600 2201811598 2201811597 2201811596 2201811594 2201811590 2201811585 2201811584 2201811582 2201811579 2201811577 2201811568 2201811567 2201811561 2201811560 2119300422 2201811554 2119300424 2201811550 2201811549 2201811548 2201811545 2201811542 2201811541 2119300431 2201811539 2201811533 2119300434 2119300435 2119300436 2119300437 2119300438 2201811532 2201811530 2201811529 2119300442 2201811527 2201811526 2201811524 2124300052 2201811520 2201811519 2201811517 2201811514 2201811510 2201811507 2201811503 2124300060 2201811499 2201811493 2201811488 2201811484 2201811482 2201811481 2201811479 2201811477 2201811476 2201811474 2201811471 2201811467 2201811460 2201811459 2201811457 2124300076 2201811454 2201811453 2201811451 2201811449 2201811445 2201811444 2201811443 2124300084 2201811439 2201811434 2201811433 2201811432 2124300089 2201811431 2201811430 2201811429 2201811428 2124300094 2201811419 2124300096 2201811416 2201811415 2201811414 2124300100 2201811412 2201811411 2201811409 2201811405 2201811404 2201811400 2201811399 2201811398 2124300109 2124300110 2201811397 2201811395 2201811391 2201811390 2201811388 2201811385 2201811384 2201811383 2201811372 2201811367 2201811365 2201811364 2201811363 2124300124 2201811362 2201811361 2201811360 2201811359 2124300129 2201811355 2201811352 2201811349 2201811348 2124300134 2201811347 2124300136 2124300137 2201811339 2201811335 2201811334 2201811327 2201811325 2201811322 2124300144 2201811318 2201811309 2136400804 2136400803 2136400800 2136400799 2124300151 2136400798 2136400796 2136400795 2136400794 2136400792 2136400791 2136400789 2136400787 2136400786 2136400784 2136400781 2136400780 2136400779 2136400776 2136400775 2136400774 2136400772 2136400767 2136400765 2136400758 2136400757 2136400753 2136400752 2136400751 2136400750 2136400749 2136400747 2136400746 2136400744 2136400743 2136400742 2124300183 2136400736 2136400735 2136400733 2136400732 2136400731 2136400730 2136400728 2136400727 2136400725 2136400723 2136400722 2136400720 2136400718 2136400717 2136400715 2136400712 2136400711 2136400708 2136400707 2136400702 2136400700 2136400699 2136400690 2136400688 2136400683 2136400680 2136400679 2136400676 2136400674 2136400671 2136400670 2136400666 2125900452 2136400660 2136400659 2136400658 2136400657 2136400656 2136400655 2136400654 2136400651 2136400650 2136400649 2136400648 2136400647 2136400643 2136400641 2136400640 2136400636 2136400634 2136400633 2136400630 2136400629 2136400628 2136400626 2136400624 2136400617 2136400615 2136400612 2136400611 2136400610 2136400604 2136400600 2136400598 2136400597 2136400596 2125900486 2136400595 2136400594 2136400592 2136400591 2136400590 2136400588 2136400587 2125900494 2136400586 2136400583 2136400582 2136400581 2136400579 2136400578 2136400574 2136400573 2136400571 2136400570 2136400567 2136400566 2136400562 2136400556 2135000750 2135000749 2135000748 2135000746 2135000742 2135000741 2135000739 2125900516 2135000737 2135000734 2135000730 2135000729 2135000728 2135000727 2135000725 2135000722 2135000721 2135000718 2135000717 2135000715 2135000714 2135000710 2135000707 2135000702 2135000701 2135000699 2135000697 2135000696 2135000695 2135000690 2135000689 2135000688 2135000687 2135000683 2135000682 2135000680 2135000673 2135000670 2135000664 2135000663 2135000661 2135000660 2135000659 2135000658 2135000656 2135000655 2135000654 2135000645 2135000639 2135000636 2135000633 2135000632 2135000628 2135000625 2135000624 2135000623 2135000621 2135000615 2135000613 2135000612 2135000610 2135000604 2135000603 2135000602 2135000600 2135000599 2135000597 2135000589 2135000588 2135000586 2135000585 2135000583 2135000581 2135000575 2135000573 2135000572 2135000571 2135000570 2135000568 2135000564 2135000563 2135000562 2135000561 2135000558 2135000557 2135000555 2135000554 2135000546 2135000542 2135000540 2135000533 2135000529 2135000526 2135000523 2135000520 2135000512 2135000509 2130700984 2130700975 2130700961 2213800316 2213800288 2213800282 2213800250 2213800239 2213800184 2212201117 2212201114 2212201108 2212201105 2212201104 2212201098 2212… See the official FDA source for the complete identifier list. | Not provided in the normalized record | Ongoing |
Nov 29, 2023
Recall initiated
Date recorded by the FDA.
Dec 20, 2023
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.