FDAFDA · Food and drugs·Recall number Z-2326-2018
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
Published July 4, 2018 · Recall initiated: April 16, 2018
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
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- St Jude Medical Inc.
- Distributor
- U.S. Nationwide distribution
- Lot
- Serial #: 1015752 730063 739101 737664 1100971 1220399 1220292 1220290 1220402 1220289 1220397 1220296 790402 1220298 1220297 1220302 1220398 1220300 1220304 1011008 1045234 727133 727125 1015722 769238 782698 806935 1203620 824778 1194681 1194692 1142920 1142348 1142916 761491 763173 768968 746500 773404 790396 807191 805967 761487 769242 749537 761680 720899 788660 769286 782672 761268 784460 825005 717555 736459 810157 805939 815815 824979 790367 725376 740816 816153 805857 761277 810470 761544 795775 787617 810502 782965 782595 716018 810139 795160 714115 763261 759507 760107 756103 761270 746528 751518 759307 752216 729982 739033 746540 784581 739855 733125 715856 746556 721983 810191 782611 1045235 784269 720881 717536 720903 769225 810648 1193445 810477 768943 714157 815756 715461 1043121 720930 715656 1000812 714194 1043232 815769 1047169 769275 810506 782683 1000878 1131834 1002830 806928 745695 1010975 1002659 789012 1131844 769260 807177 745697 752813 747715 745628 751735 746480 752547 752508 746561 747776 747741 746497 746536 747683 746517 751684 747728 749993 746479 745682 747766 751728 746537 745710 746509 745671 743847 747746 745676 745644 745670 743912 745677 749872 745488 795229 745685 750012 745463 747716 749452 745469 745658 745484 745662 745675 745512 745627 749790 745652 745478 763214 745648 749995 747758 749801 750058 750040 749457 747753 749505 752824 750052 749448 750043 749529 750082 745432 749517 749488 749441 749467 749498 747679 750063 750073 749878 747747 750080 749837 750075 750005 750032 806791 749846 749873 749775 750053 749877 749447 749802 749494 747689 749540 749838 749807 750084 749831 745614 749472 749773 750074 747771 749470 750048 749533 749535 749440 749820 750079 749456 750067 749445 749478 749780 749832 747712 749823 745707 746531 749429 745477 745508 752530 749849 747711 745495 749507 745637 749490 747682 749542 750039 745683 745688 747704 745511 1002829 749491 746483 745709 1017808 749767 750034 752212 750023 747690 749530 747735 784544 749853 747775 749485 747736 752873 745621 749794 745422 749531 749852 749883 749455 749538 746496 750029 746471 749422 747706 750070 747750 749785 749418 749519 749869 749808 749434 746562 749813 750013 1009586 749464 749825 749783 747732 752520 745686 1017841 747761 752523 752542 746558 751696 746477 747774 745441 751549 752154 746486 745467 751683 747692 745706 743883 749419 747691 749788 747748 746519 746524 747698 747686 752483 747726 747721 746539 761790 746473 752544 749862 746495 752215 751673 752247 784262 752471 749851 746523 746555 749772 749881 749842 746544 749473 727145 784509 759455 825018 747764 811558 1001660 784559 790417 1018468 1015745 782697 795755 1043267 715584 715519 714165 714164 715563 714246 715483 715846 714167 714179 714239 714142 715829 715524 725400 715730 714140 714240 714233 714226 715724 714154 714109 714238 714099 715548 714211 715480 715600 715698 715609 714221 714145 769232 715482 715465 714121 714132 715541 714137 714191 714135 714143 714152 714176 714198 714159 714118 715607 714133 805880 805925 805931 805812 1045216 805861 805906 807162 805914 807173 807194 806734 807403 1010426 805908 805815 805892 806742 805818 807292 807338 805889 807157 806931 807135 805899 807138 806993 805985 805888 805844 807121 811605 806722 806908 749526 805998 805986 805849 805870 805954 805995 806005 805887 806948 811136 805875 805824 805828 805852 805923 805879 807165 805891 807197 805905 805947 805936 805991 807324 806944 805992 805981 805882 805851
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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